Chronic Pain III: Special Issuesby William W. Deardorff, Ph.D, ABPP.
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COURSE OUTLINE
Introduction to the Course and Overview Learning Objectives Medications for Chronic Pain Why Do I Need to Know This Stuff? Anti-inflammatories and Acetaminophen Muscle Relaxants Opioids Understanding Key Concepts in Pain Medication Management Antidepressants Antianxiety Agents Sedative and Hypnotics Anticonvulsants Helping Your Patient be an Informed Consumer Chronic Opioid Therapy for Chronic Noncancer Pain Assessing Opioid Addiction Potential in the Chronic Pain Patient Aggressive Conservative Treatment The Deconditioning Syndrome Physical Reconditioning Principles for a Chronic Pain Reconditioning Program The Quota System Pacing Aerobic Conditioning Family, Friends and Exercise Spinal Cord Stimulation Medical Conditions Associated with Neuropathic Pain Theory of Spinal Cord Stimulation Spinal Cord Stimulation Components Phases of Spinal Cord Stimulation Psychological Screening Evaluation SCS Test Stimulation Phase Permanent Implantation Phase Patient Follow-up Complications Associated with Spinal Cord Stimulation Procedural and Technical Contraindications Pre-implant Psychological Screening Purpose: Why is it so Important? Components of the Pre-implant Biopsychosocial Screening Presenting the Pre-implant Screening to the Patient Clinical Interview and Review of Medical Records Psychological Testing Battery SCS Pre-implant Screening Categories of Assessment Patient Categorization: A Scorecard Approach Enhancing the Validity of the Pre-implant Trial Sample SCS Screening Evaluation Report Resources References INTRODUCTION AND COURSE OVERVIEW
The previous course (Chronic Pain Management II: Evaluation and Treatment) reviewed procedures that are directly applied by the pain management clinician relative to chronic pain. However, the expertise of the pain management clinician (especially in the use of behavioral principles) also allows for other collaborative interventions that can be very powerful in treating chronic pain. In this role, the pain management clinician is intimately involved in the management of the patient but primarily adjunctive to other health care providers. Some of the most commons areas include medication management, long-term opioid treatment, physical re-activation, and pre-implant psychosocial evaluation screenings. Of course, the evaluation and treatment of chronic pain patients relative to these “special issues” cannot be done outside of a multidisciplinary context and require a close and collegial working relationship with the other healthcare providers. Of course, this should be the case in providing any effective treatment of chronic pain patients. For this type of treatment to be successful, these other providers must be respectful of what behavioral health has to offer in terms of applying psychosocial principles to medical care and treatment.
This course assumes knowledge of the information presented in first two courses in the series: Chronic Pain Management I: Concepts and Chronic Pain Management II: Evaluation and Treatment.
LEARNING OBJECTIVES
· List the seven groups of medications used in chronic pain · Explain the concept of long term opioid medication treatment · Summarize the difference between addiction, dependence and tolerance · Design a basic chronic pain reconditioning program · List the phases of Spinal Cord Stimulation
MEDICATIONS FOR CHRONIC PAIN
This section is an overview of medicines that are commonly used in the treatment of pain. It is important for the pain management clinician working with chronic pain patients to be familiar with the various medications that are commonly used in the treatment of chronic pain. The issue of long term opioid maintenance will be discussed in a separate section.
Why Do I Need to Know This Stuff?
You may be asking why the pain management clinician working with chronic pain patients needs to know information about medications. Since the pain management clinician will generally spend more time with the patient than the treating physician, he or she is in a unique position to monitor such things as:
· possible side-effects the patient might be experiencing to the medicines · whether or not the patient is taking the medication as prescribed · the patient’s ongoing response to the medication regimen · any evidence of medication abuse, “doctor shopping” or use of illicit drugs
Working with chronic pain patients necessitates being in close contact with the other healthcare providers (physician, physical therapy, etc). The management of medications is one area that the pain management clinician should work closely with the treating physician to develop an appropriate treatment program for the chronic pain patient.
In addition to providing psychological treatment in the form of chronic pain management, the pain management clinician is also a patient advocate. For instance, it is not unusual for the astute pain management clinician to discover that a chronic pain patient has been on an extensive medication regimen for years and not had regular liver and kidney function tests. Or, the pain management clinician may be the first to hear about significant (and serious) side effects to medications that have been occurring for quite some time but the patient has not told his or her physician (e.g., bleeding, bruising, etc). I make it a rule to ask patients the following questions on a regular basis:
If problems are discovered, encourage the patient to schedule an appointment with his or her physician. At the next visit, verify that the patient followed through and was actually re-evaluated by his or her doctor. With the appropriate release of information, contact the physician about important issues.
Traditional medicine will often look to medicating chronic pain suffering without providing other treatments (e.g., physical conditioning, relaxation training, and mind-body approaches), which are more likely to have long-term benefit. In the vast majority of cases of chronic pain, if a decision is made to use medication, it should be done in conjunction with a treatment plan including other approaches. Medications used for chronic pain can be divided into seven general categories, as follows:
1. Nonsteroidal anti-inflammatories and acetaminophen 2. Muscle relaxants 3. Opioids 4. Antidepressants 5. Antianxiety agents 6. Sedatives (hypnotics) 7. Anticonvulsants
Nonsteroidal Anti-inflammatory Drugs (NSAID) and Acetaminophen.
These medications have been placed together since they are commonly used in the treatment of chronic pain. NSAID’s have been around for over 100 years. They are a class of medications that, as their name implies, have the purpose of reducing inflammation. Inflammation can also be thought of as a "swelling" and includes a process whereby local chemical irritants are released from the involved tissue. These chemicals have several effects on the surrounding tissue, including altering the normal patterns of blood flow and irritating the nerve endings that carry the pain signal (nociception). As an example, when you suffer from a bruise, you will see a black-and-blue mark or bump on the skin, including swelling. This happens because of a local inflammatory reaction in which various chemicals are released, causing leakage of fluid into the local area, irritation of nerve endings, and changes in blood flow. The chemicals released during the inflammatory process include prostaglandins, which have an ability to stimulate various cells associated with the inflammatory process. If not brought under control, this inflammatory process can persist and impede healing, as well as being painful. NSAID’s are directed at stopping the inflammatory process by inhibiting the production of prostaglandins.
One of the original anti-inflammatory drugs commonly used is aspirin. Besides reducing inflammation, aspirin also has the properties of being an analgesic and antipyretic (antifever) medication. In many studies aspirin has been found to be as effective as other prescription medications for chronic pain. Although aspirin remains the first and most widely used of the NSAID’s, it can be associated with several side effects including gastrointestinal upset, ulcers, and increased bleeding tendencies, among others. Using enteric-coated forms of aspirin to protect the GI tract can help with some of these side effects.
There has been a rapid proliferation in the development of various classes of anti-inflammatory agents. All of these have certain pharmacologic similarities in that they inhibit the synthesis of prostaglandins. The most commonly known NSAID’s presently used in the United States, aside from aspirin, include ibuprofen (Motrin and Advil) and naproxen (Naprosyn and Aleve). People use these NSAID’s for everything from sports injuries to menstrual cramps to headaches. One of the newest categories of NSAID’s is the COX-2 inhibitors including Vioxx, Celebrex and Bextra. The COX-2 inhibitors are purported to provide the anti-inflammatory action without the GI problems. Vioxx was recently completely removed from the market due to a pattern of serious cardiac side effects. Other medications in the COX-2 category are now under closer scrutiny to determine safety of long-term use. It should be noted that cardiovascular risk extends to all non-aspirin NSAID’s with the highest risk found in the Cox-2 agents.
Because NSAID’s can cause nausea and GI upset, the medication should only be taken with meals. NSAID’s can also increase bleeding time, which slows down blood clot formation and increases the possibility of bruising. Less common side effects include tinnitus (ringing in the ears), light-headedness, and gastritis. Many of the NSAID’s are metabolized primarily by the kidneys and some by the liver, so these organs need to be checked regularly if there is chronic use. The main reasons not to use NSAID’s include ulcer disease and bleeding problems. NSAID’s should be prescribed on a regular dosing schedule for most conditions and usually continued for at least two weeks. This allows for establishment and maintenance of a therapeutic blood level.
It should be noted that patients will often have a tendency to discontinue the use of their NSAID’s within the first couple of days of treatment when they start to feel better. One often sees a recurrence of symptoms from this discontinuation of the NSAID. As the physician often has a goal of obtaining a certain blood level of medication when prescribing it, the patient should be cautioned to discuss with him or her any desire to stop the medication prematurely or to change the dosage, even if the symptoms seem to have disappeared. Also NSAID’s should usually be used on a time-limited basis due to the side effects listed above. Acetaminophen (Tylenol) is a very commonly used analgesic both alone and compounded with other medicines. It has pain relieving properties but no anti-inflammatory effect. Similar to the NSAID’s, acetaminophen should be taken for at least several days to have an effect on chronic pain. In chronic pain patients, the acetaminophen is most often taken combined with some other analgesic. This is usually codeine (e.g., Tylenol #3), hydrocodone (e.g., Vicodin, Lorcet, Norco) or oxycodone (Percocet). It is generally recommended that patients not exceed a total of 4000 mgs per day of acetaminophen from all sources due to possible negative effects on liver function. It is important for the pain management clinician to be aware of these issues, since he or she may be the first to uncover a problem. A common example might be the patient who is taking 5 Vicodin per day as prescribed by the physician (500 mg of acetaminophen per pill yielding 2500 total) and then decides to add an over the counter Extra Strength Tylenol with each dose to try and get better relief (5 per day at 500 mgs each yields 2500 total). The total dose is 5000 mg per day, which is well over the recommended amount. Add to this a patient who has an alcohol drink or two each evening and problems can develop. Often, the patient will not mention adding the OTC medications to their doctor and, as discussed previously, blood tests may not be regularly scheduled. When this is discovered, the issue must be discussed with the patient and a follow-up visit with the physician scheduled. Muscle Relaxants
Muscle relaxants (or skeletal muscle relaxants) are divided into two categories: antispastics (for conditions such as cerebral palsy and multiple sclerosis) and antispasmodics (for musculoskeletal conditions). This discussion will focus on the antispasmodics for the treatment of musculoskeletal conditions since this is a common complaint in chronic pain (See and Ginzburg, 2008a, 2008b).
Muscle relaxants are usually prescribed with the goal of reducing muscle spasm and generally should be used on a limited and short-term basis. In the case of chronic pain, this might include short term use for pain exacerbations. How muscle relaxants work remains somewhat controversial. Many of these medications are known to work through the central nervous system and thereby secondarily relax the muscles by “relaxing” the brain. There are several muscle relaxants that appear to work directly on the cells of the muscle itself by decreasing the "hypercontractual state" (overcontracted or in spasm). However, these also have known effects on the central nervous system. Among the more commonly prescribed muscle relaxants in use today for musculoskeletal disorders include:
· Soma (carisoprodol) · Flexeril (cyclobenzaprine) · Skelaxin (metaxalone) · Robaxin (methocarbamol) · Valium (diazepam) · Zanaflex (tizanidine)
All of the muscle relaxants are known to have effects on the brain, including a slowing of overall mental functioning and sedation. In addition they may have an anxiolytic effect (in fact Soma is metabolized to meprobamate, an anxiolytic). Efficacy of the muscle relaxants appears to diminish over time and there is the risk of dependence. Although it is recommended that their use be short term, one will often see chronic pain patients taking these medications at fairly high doses over the long term. In many cases, a careful assessment indicates the patient is using the medication more for its sedative (and possibly anti-anxiety effects) than muscle relaxation. One of the muscle relaxants purported to be non-sedating is Skelaxin; however, drowsiness is listed as a side-effect. Long term use of muscle relaxants can cause significant problems. For instance, patients can become dependent on muscle relaxants especially when using them as a sleep medication. In addition long-term use of these medications may potentially promote symptoms of depression. Many muscle relaxants (most notably Valium) also play a role in reducing anxiety and, although this might be helpful for a short period of time in patients with acute pain or a chronic pain flare-up, they are addictive. Muscle relaxants should generally not be prescribed if it becomes clear that they are being used for anxiety and agitation rather than spasm. Unlike NSAID’s, some physicians feel it can be appropriate to utilize muscle relaxants on an as-needed basis in the treatment of chronic pain. If the spasm is severe and not responding to ice, heat, or stretching, then muscle relaxants can be used as an adjunct for short-term relief. They should never be used as a substitute for these other methods of reducing spasm. The most common side effects of muscle relaxants relate to their depressant effects on the central nervous system. Dependency on the medication is the other major concern in view of their role in reducing anxiety, helping with sleep, and causing somewhat of a euphoric state in some individuals. Dosages of these medications vary significantly.
In summary, the role of muscle relaxants should be quite limited to cases where muscle spasm is a well-defined component that is not responding to physical interventions, such as ice, heat, and stretching. For chronic spasms, biofeedback and relaxation training would be more appropriate. Long-term use of muscle relaxants is generally not indicated for chronic pain. Some specialists will use muscle relaxants rarely for two reasons. First, there is controversy as to whether muscle spasm is even significant in many musculoskeletal chronic pain problems (e.g., back pain). Second, the muscle tension, if it is present, may actually serve a protective function. These reasons, as well as those listed above, underscore that muscle relaxants should only be used in clear cases of muscle spasm when other modalities have not been effective and only on a time-limited basis.
Opioids
This section will be an overview of the use of opioids in chronic pain treatment. A subsequent section, Chronic Opioid Therapy for Chronic Noncancer Pain, will specifically address long-term opioid maintenance. Opioids and related compounds (e.g., semisynthetics such as oxycodone and synthetics such as methadone) are perhaps the most commonly used medications for all types of pain. The evidence for their efficacy in acute pain (including cancer pain) problems is without question. The use of opioids for chronic noncancer pain is widespread but controversial.
There are five important concepts in the long-term use of opioids with chronic pain patients: tolerance, pseudotolerance, physical dependence, addiction, and pseudoaddiction. Patients very often confuse these terms and concepts causing problems with medication compliance. Also, patients often have a fear of addiction, which causes non-compliance to the medication regimen and, in turn, poorer pain control. Careful explanation of the following concepts can be helpful for patients who are skeptical of appropriate pain medication regimens. Understanding Key Concepts in Pain Medication Management
Patients should understand that a large body of research has demonstrated that if pain medication is given for a legitimate reason (e.g., related to surgery), addiction to analgesics is very unlikely (Cleary & Backonja, 1996; Porter, 1980; Portney, 1994; Zenz, Strumpf & Tryba, 1992; See also Chou et al., 2009, for a review). The fear of addiction is prevalent among chronic pain patients and may cause reluctance to taking appropriate doses of medication for adequate pain control. To help ease patient fears, it is important to help them (and healthcare professionals) understand the difference between important pain medication concepts: tolerance, pseudotolerance, physical dependence, addiction, and pseudoaddiction (See American Academy of Pain Medicine, the American Pain Society & American Society of Addiction Medicine, 2001):
Patients (and healthcare professionals) often confuse these concepts. Both tolerance and dependence commonly occur in pain medication use and can be readily managed by the physician specializing in this area. Tolerance can be managed by adding other non-addictive medicines that help the narcotics work better and/or emphasizing non-medication pain control techniques. Dependence is addressed by slowly tapering the pain medication and, possibly, adding other medication to control withdrawal symptoms, as appropriate. The pain management clinician is often called upon to help the physician differentiate among symptoms of possible addiction, pseudoaddiction, and pseudotolerance.
Dr. Richard Sternbach has identified how tolerance and dependence on pain medicine can actually lead to higher levels of pain perception. Patients who have attained higher levels of pain medicine use will occasionally attempt to decrease their use. When they do attempt this decrease, withdrawal symptoms occur, the most prominent of which is usually an increase in pain. The patient will state that he or she does not have a "craving" for the medication except to relieve the pain. This increase in pain, in addition to the lack of craving, is then used as a rationale for the patient (and the patient's doctor) to once again increase the analgesic use, stopping the withdrawal symptoms, and decreasing the pain. This pattern will only lead to higher levels of pain, dependence, and tolerance.
Dr. Sternbach has identified this phenomenon as a "conditioned pain response." In this process, at the early stages of pain medication use the patient waits until the pain is very severe before taking the medicine. The pain medicine results in a decrease in pain, which is a positive reinforcer. Anything that results in positive reinforcement is likely to be done again or to occur again. Therefore the next time the patient has pain, he or she is more likely to take a pain pill. This process continues until tolerance and dependence develop. When this occurs, the withdrawal symptom of increased pain is more likely to occur as the medication wears off. As Dr. Sternbach says, "The pain becomes more severe as a signal to replenish the supply of narcotics which the body has now come to need." This, then, becomes a conditioned pain response in which higher pain levels are reinforced by the pain medicine. It should be noted that this process is not related to imaginary pain or addictive behavior.
Aside from the possibility of a conditioned pain response, the opioids are not without significant side effects. Long term opioid use includes risk factors of constipation, itchiness, hypogonadism (shrunken testicles), interaction with other medication, respiratory depression, and accidental overdose. In addition, recent studies have identified the potential for another side-effect to long term opioid use: opioid-induced hyperalgesia (increased pain perception; Mercadante, Ferrera, et al., 2003). In this condition, the pain perception is made worse by the long term opioids.
A significant controversy exists among medical professionals in determining the appropriate long-term use for narcotic analgesics in chronic noncancer pain. There is widespread acceptance that it is reasonable to use narcotic analgesics for pain relief in the short term when the patient has severe pain and is unable to obtain relief by any other means. However, there is controversy when it comes to using these medications for chronic noncancer pain, and most physicians prefer other pain-control approaches. If one sees a chronic pain patient on long-term opioids, he or she is most likely being managed by a physician that specializes in pain management (usually an anesthesiologist or physiatrist).
Any analgesic taken long-term should be used on a "time-contingent" basis rather than ''as-needed.'' On a time-contingent schedule the medication is taken on a fixed schedule rather than according to symptoms, regardless of the pain level. For instance the schedule might be one tablet every four hours. The idea behind this approach is to keep the pain relieving effect constant, avoid the ups and downs of the as-needed approach, and prevent the conditioned pain response from occurring. It can also prevent severe pain episodes by catching the pain early.
Some of the newer time-release opioids have taken care of this time-contingent dosing problem since the dosing is either once or twice per day (e.g., Oxycontin, Kadian). It is always important for the patient to utilize the lowest level of pain medicine necessary. This will help avoid tolerance and keep dependence from occurring, in addition to ameliorating the side effects of the medicine. One should always encourage the use of other non-medication approaches to pain control and increasing function (e.g., psychological and behavioral pain management interventions). Antidepressants
Antidepressants are playing an increasing role as a medication adjunct in the treatment of chronic pain problems. All classes of antidepressant medications have been studied including the tricyclics, selective serotonin reuptake inhibitors (SSRI) and the selective serotonin and norepinephrine reuptake inhibitors (SNRI). Extensive research is showing that certain antidepressant medications can provide pain relief in many chronic pain conditions independent of their antidepressant effect. It should be underscored that the analgesic effect is seen even in patients who are not depressed. Therefore the pain relief appears to occur independent of the antidepressant effect. Extensive research is presently being done to better understand the exact roles of antidepressants for pain management. Some of the most widely used antidepressants for pain control in the area of chronic pain are the tricyclic antidepressants (TCA’s) such as the following:
· Imipramine (Tofranil) · Amitriptyline (Elavil) · Doxepin (Sinequan) · Nortriptyline (Pamelor) · Desipramine (Norpramine) · Clomipramine (Anafranil)
There is some indication that the Selective Serotonin Reuptake Inhibitors (SSRI) may have some use in certain chronic pain conditions (e.g., painful polyneuropathy, nerve injury pain) but their analgesic effect has not been firmly established. There is also ongoing research into the SNRI medication (e.g. Cymbalta, Effexor, Pristiq). There is some support for the analgesic benefit and these medications in neuropathic pain syndromes. Of course, the SSRI’s and SNRI’s may be appropriate to treat depressive symptoms in a patient with chronic pain.
Although the exact mechanism remains somewhat unclear as to how these medicines afford pain relief, they are considered to be helpful to varying degrees in different patients. The choice of antidepressant medication will depend on the symptoms the patient is experiencing. Some of the antidepressants have sedative properties, while others have an energizing effect. In addition different antidepressants will affect different brain neurotransmitters (serotonin, norepinephrine, dopamine). Some of the factors to be considered in choosing an antidepressant are as follows.
First, one might consider the role that antidepressants have in improving restful sleep in addition to decreasing pain. Many chronic pain patients, especially those with neuropathic (nerve) pain, have great difficulty obtaining restful sleep. The sedative properties of some of the antidepressants can be very helpful in normalizing sleep patterns while at the same time playing a role in the reduction of pain. The antidepressants seem to provide better restful sleep and other positive benefits (e.g., pain relief) than sleeping medications. In addition, unlike most sleeping medications, the antidepressants have no addictive properties and can be used over the long term. Dose ranges for antidepressants for pain versus depression can be seen in the Table.
These medicines are also sometimes intended to have some role in combating depression, which is commonly seen in varying degrees associated with chronic pain suffering (as discussed previously). However, it should be reiterated that even if the patient is not clinically depressed, there appears to be a property in many of the antidepressants that decreases pain. This pain relief property occurs at dosage ranges much less than those used in the treatment of depression. For instance, a typical dose of Elavil for chronic pain would be approximately 50 to 75 milligrams, whereas the antidepressant dose might typically be 100 to 150 milligrams or more. There are also many patients who see a significant reduction of their pain and improvement in sleep with even lower doses of antidepressants.
Side effects will vary depending upon the medication used. Common side effects include dry mouth, blurred vision, constipation, urinary retention, sedation, and nausea, among others. Side effects will usually be experienced when starting antidepressant medication and dissipate after two to three weeks or sooner. Be sure and discuss with the patient that mild side effects at the beginning of treatment are generally to be expected, but all side effects should be reported to his or her physician. In addition it is helpful to warn the patient ahead of time that the dosages of these medications frequently have to be adjusted and tailored to the individual (which can take some time).
It may take up to several months to find both the proper dose and the proper antidepressant medication for an individual patient. Patients should communicate regularly with their physician and be well informed about changes in the doses and side effects. It is important to help patients not to get frustrated during this adjustment phase when trying antidepressant medications as an adjunct in controlling pain. Many patients are concerned about becoming chronically dependent on these medications, as well as of the possibilities of long-term side effects. It should be explained that antidepressant medicines are not addictive, and tolerance in the sense of narcotic analgesics does not develop. Many chronic pain patients are hesitant about trying these medications due to the stigma attached to taking psychotropics. This issue should be discussed fully with the patient.
It is important to stress having the patient also employ self-management techniques, such as relaxation procedures, cognitive behavioral techniques, meditation, and exercise. In certain cases the pain management clinician may identify a clinical depression in the chronic pain patient. In these cases, appropriate use of antidepressant medications at therapeutic levels may be indicated and a referral for evaluation is certainly indicated.
Antianxiety Agents
Antianxiety agents (also termed anxiolytics or minor tranquilizers) are occasionally used on a short-term basis in chronic pain for their role in decreasing anxiety and helping with sleep. The most widely used anxiolytics are known as benzodiazepines, which include such medications as Valium (diazepam), Klonipin (clonazepam), Ativan (lorazepam) and Xanax (alprazolam). As discussed previously, Valium is also used as a muscle relaxant and most likely exerts the majority of its effect on the central nervous system. Long-term use of the anxiolytics in chronic pain patients is generally not recommended. Most physicians generally discourage the use of these agents for anything but very short periods and in very specific cases. If the chronic pain is associated with a high degree of anxiety and agitation, these medications can be useful. As with the other medications, they should be used as part of a comprehensive approach to the chronic pain problem including teaching the patient other non-medication techniques for managing the anxiety, sleep disruption, etc.
There are certain patients with more severe anxiety disorders who also suffer from a chronic pain problem. These patients may require more long-term use of anxiolytics when they do not respond to other interventions. The patient should be followed closely and regularly by a physician familiar with the use of these medicines in the chronic pain population (e.g., a psychopharmacologist or pain management physician). The pain management clinician can help in the management of these medications by assessing the patient use and response at the regular follow-up visits as discussed previously. Any problems can be reported to the physician managing the medications.
Common side effects of the benzodiazepines include drowsiness, sedation, and short-term memory loss, among others. Many of these side effects are eliminated by adjusting the medication dose. Tolerance and dependence do develop when using these medications, just as in the case of pain medicines. Care should be taken to avoid alcohol while taking these medications. The patient should never abruptly stop taking benzodiazepines and they must be tapered appropriately as managed by the patient’s physician. As with the other medications, it is not uncommon for the treating pain management clinician to be the first practitioner to find out that the patient is not following the medication prescription properly (e.g., abruptly stopping the medication, increasing the dose, consuming alcohol or other medication that might have a synergistic effect, etc). Sedatives and Hypnotics
Sedatives (also termed hypnotics) are used for sleep. There are a variety of medications classed in this group, but they generally include: benzodiazepines (Dalmane, Restoril, Ambian, Sonata), non-benzodiazepine benzodiazepine receptor agonists, barbiturates (Amytal, Nembutal, Seconal), chloral derivatives (chloral hydrate), and antihistamines (Benadryl). The barbiturates and chloral derivatives are rarely used now due to dangerous side effects and will not be discussed. In addition to these categories, a new medication has been released (Rozerem) with a unique mechanism of action (melatonin receptor agonist). Benzodiazepines. The most commonly prescribed medications for sleeping problems include two the benzodiazepines and the non-benzodiazepine benzodiazepine receptor agonists. Although all of the benzodiazepines are used for the treatment of insomnia, the first five in the list are used most commonly for sleep disorders.
Dalmane (Flurazepam)
The benzodiazepines have been the most commonly used medications in the treatment of insomnia and are certainly safer than some of the older sleeping medications such as the barbiturates (Amytal, Nembutoal, Seconal). However, there have been concerns regarding inappropriate use and abuse of these medications. These medications are generally recommended only to be used on a short term basis since physical tolerance and dependence can develop. In addition, these medications can often produce a “hangover” effect the following day.
Non-benzodiazepine benzodiazepine receptor agonists. In recent years, a newer class of medications has been developed often termed the “non-benzodiazepine, benzodiazepine receptor agonists”. These newer medications appear to have better safety profiles and less adverse effects. These medications are associated with a lower risk of abuse and dependence than the benzodiazepines. Examples of medications in this class include:
Ambien (Zolpidem)
These medications are known to reduce the time it takes to fall asleep and, thus, their effects are quite similar to those in the benzodiazepine class. These medicines appear to have different characteristics and may be used in different ways. Again, although these medications are safer than the benzodiazepines, it is not recommended that they be used on a long term basis (except Lunesta which will be discussed subsequently).
· Ambien. This sleeping pill has effects that persist later into the night and may help the individual stay asleep longer. Thus, it must be taken at bedtime and may be used when the individual has trouble falling asleep and/or staying asleep. Ambien CR is now available which is a longer lasting, time-released version of the medication.
· Sonata. This sleep aid is generally used for those individuals having trouble falling asleep. Therefore, it is often taken at bedtime or later such as when awakening during the night as long as there are at least four or more hours left to sleep.
· Lunesta. This sleep aid was approved by the FDA in December of 2004 as a new, longer lasting sleeping pill. Clinical trials have demonstrated that Lunesta helps people get to sleep faster, similar to Ambien and Sonata. However, it appears that it also helps the individual stay asleep through the night. The FDA has approved Lunesta for patients who have difficulty falling asleep as well as those who are unable to sleep through the night. Lunesta has about a six hour half life, so it is more likely to maintain sleep. Due to its long half life, Lunesta must be taken immediately before bedtime and the individual should make sure that he or she has a full eight hours devoted to sleeping before taking it. As with the other medications, side effects can occur, including daytime drowsiness, dry mouth, and dizziness. Unlike the other medications in this class which are recommended only for use on a temporary basis, Lunesta is approved for longer term use.
Melatonin receptor agonist. Rozerem (ramelteon) is the first prescription insomnia medication with a novel mechanism of action to be released in 35 years. It has been approved by the FDA and in use for many years. Rozerem has a unique mechanism of action that selectively targets specific receptors in the brain that are responsible for controlling the body’s sleep-wake cycle. It works by mimicking melatonin, a naturally occurring hormone that is produced during the sleep period. Rozerem may have an advantage over the other benzodiazepine and non-benzodiazepine classes for the following reasons:
In using these medications one must first look at the reasons for sleep problems. If they are related to depression, then an antidepressant should be used. If they are related to anxiety, then an anxiolytic agent should be used. If they are related to pain, then an analgesic or low-dose sedating antidepressant might be most appropriate. If none of these is the case, then consideration of a sedative for short-term use may be appropriate.
In choosing a sedative, the least addictive should be tried first. Using Benadryl (50 to 150 milligrams at bedtime) is a very good first choice. If that is ineffective, the non-benzodiazepine, benzodiazepine receptor agonists can provide a good sedative effect. These are relatively safe medicines and are the least disruptive to certain types of sleep patterns. The use of barbiturates has fallen into disfavor due to the potential for abuse and the availability of the much safer non-benzodiazepine, benzodiazepine receptor agonists and the benzodiazepines. Using alcohol as a sedative is not indicated since it causes disrupted, non-restful sleep as well as early morning awakening and depression. Any sedative should be used only as needed and on a limited basis if possible. Teaching the patient other techniques for relaxation as well as good sleep hygiene is always indicated. This includes such things as going to bed and awakening on a consistent schedule, practicing relaxation exercises to fall asleep and not doing anything stressful in bed (e.g., paying bills). The pain management or behavioral health clinician can be very helpful relative to these non-medicine approaches. Anticonvulsants
One of the newest classes of medications being used for certain chronic pain conditions are drugs originally developed for seizure disorders (called antiepileptics, anticonvulants or neurologics). The various categories of these medications will not be discussed here but four of the commonly used medicines are Lyrica (pregabalin), Neurontin (gabapentin), Depakote (divalproex sodium) and Tegretol (carbamazepine).
The anticonvulsants are generally used for specific types of chronic pain syndromes including the following:
· Painful polyneuropathy · Postherpectic neuralgia · Central poststroke pain · Trigeminal Neuralgia · Other neuropathic conditions
These medications are often used in chronic pain that is of a neuropathic nature and this is often associated with pain sensations described as burning, radiating, lancinating, stabbing, etc. Many patients have trouble with the side effects of these medications including sedation, dizziness, headache, nausea, vomiting, and cognitive changes.
HELP YOUR PATIENT BE AN INFORMED CONSUMER
Beyond direct treatment of the chronic pain condition, the pain management clinician also acts as a patient advocate or “coach”. In this role, the pain management clinician is teaching the patient to work effectively within the health care system to gain the maximum benefit from medical treatments and avoid being actually injured by the medical interventions. Unfortunately, iatrogenic problems in the treatment of chronic pain are not uncommon (e.g., medication problems, avoidable surgeries, etc.). One area in which the pain management clinician can provide very helpful “indirect” treatment is to teach the patient to be an active consumer relative to his or her medication regimen. I utilize the following handout for patients:
CHRONIC OPIOID THERAPY FOR CHRONIC NON-CANCER PAIN
There are some physicians and researchers who feel that long-term use of opiates in very select patients with chronic pain can be an appropriate treatment and this does have some support in the clinical research. In this subset of patients who are deemed appropriate for this treatment, the goal is to achieve sustained analgesia and increased function without the occurrence of significant side effects or aberrant behavior (addiction, abuse, etc). However, this approach continues to be highly controversial due to fears of addiction, side effects, physical dependence, and tolerance (See Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain published jointly by the American Pain Society and American Academy of Pain Medicine, Chou et al., 2009).
Dr. Russell Portenoy is probably best known for his research and interest in this area. He, and others, feel that there is a subpopulation of chronic noncancer pain patients who are able to obtain at least partial pain relief from chronic opioid therapy without the development of toxicity or significant tolerance. He states that substance abuse behaviors may occur, but that these are uncommon if patients are carefully selected. Patients with a history of substance abuse tend to be at risk for developing problems in this regard. The most common physical side effects of long-term pain medicine use include persistent constipation, insomnia, and decreased sexual function. In addition there may be cognitive difficulties (trouble thinking clearly or focusing) and sedation initially, but it appears that these effects tend to diminish over time, although some patients do report continued "mental clouding" sufficient to impair functioning.
In pursuing such a treatment approach with chronic non-cancer pain patients, Dr. Portenoy has proposed very specific guidelines for patient selection and evaluation of the treatment. As can be seen from the screening criteria, the assistance of an appropriately trained pain management clinician is indicated for both evaluation and ongoing treatment. The screening and management criteria are as follows:
As can be seen from the screening criteria, it appears that very few noncancer chronic pain patients might be appropriate for this type of approach. Patient selection is critical, as is working with a physician who is knowledgeable of this type of treatment. Certainly, prior to utilizing this kind of approach, a behavioral/psychological approach to pain management including physical and mental reconditioning programs should be attempted. Even if these are not entirely successful, they should be continued in conjunction with the long-term pain medication program.
These tenets of chronic opioid therapy (COT) for chronic noncancer pain (CNCP) have been included in the new Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain published jointly by the American Pain Society and American Academy of Pain Medicine (Chou et al., 2009) under various recommendations:
1.1 Before initiating COT, clinicians should conduct a history, physical examination and appropriate testing, including an assessment of risk of substance abuse, misuse, or addiction.
2.2 Clinicians may consider using a written COT management plan to document patient and clinician responsibilities and expectations and assist in patient education.
5.1 Clinicians should reassess patients on COT periodically and as warranted by changing circumstances. Monitoring should include documentation of pain intensity and level of functioning, assessments of presence of adverse events, and adherence to prescribed therapies.
9.1 As CNCP is often a complex biopsychosocial condition, clinicians who prescribe COT should routinely integrate psychotherapeutic interventions, functional restoration, interdisciplinary therapy, and other adjunctive nonopioid therapies.
In actual clinical practice, I have seen many patients who are receiving long-term pain medication therapy that are either completely inappropriate for this approach or who are receiving it in an incorrect fashion. All aspects of such an approach as listed previously, and included in the new guidelines, must be adhered to in an ongoing manner. Patients will often have unrealistic expectations about using opiates long-term, believing that "if my pain were gone, then I would resume my life." The chronic opioid therapy approach tends to reinforce this type of thinking, often to the exclusion of increasing functioning and improving other aspects of a person's life. In these types of cases, a multidisciplinary pain rehabilitation program that focuses on these issues rather than moving toward a chronic opioid approach might be much more beneficial. As can be seen from the literature review and new guidelines, the behavioral health practitioner should be intimately involved in the COT process both in screening and ongoing monitoring.
ASSESSING OPIOID ADDICTION POTENTIAL IN THE CHRONIC PAIN PATIENT
As mentioned previously, the pain management clinician is often called upon to help the physician determine if a patient who is on opioids is showing signs of addiction, pseudoaddiction, or pseudotolerance. Assessing opioid-induced disorders in a chronic pain population is extremely difficult especially when there is no abuse of illicit or recreational drugs. As discussed by Harden (2002), “to confuse the recreational/street abuse of drugs of any type with the private clinical decision between a doctor and patient to use these drugs for an appropriate medical indication is a serious error” (p. 8). However, psychological opioid dependency does occur in chronic pain patients within the context of being prescribed by one’s physician. As discussed in the review by Harden (2002), “psychological dependency, defined as an emotional state of craving for a drug for its euphorigenic effects or to avoid negative effects associated with withdrawal, occurs at variable rates dependent on specific characteristics of the clinical situation,” (p. 8). Psychological dependency may be in some cases a consequence of fear of uncontrolled pain rather than pursuit of euphoria or avoidance of abstinence. Harden (2002) goes on to review the research literature that suggests the presence of certain other psychiatric diagnoses (particularly personality disorders) and certain sociologic milieu may make abuse and addiction much more likely.
Chronic pain patients often have significant disease conviction, somatic preoccupation, and an externalized locus of control. These factors often lead to increased opioid-seeking behaviors in the absence of increased nociceptive input. The non-analgesic operant reinforcing effects of taking opioids may also exacerbate opioid-seeking behavior. Thus, one might look for a cluster of psychosocial and psychological factors to determine possible addiction (e.g., a personality disorder, fear of withdrawal, external locus of control, extreme somatic focus, and significant illness conviction).
Behaviorally, one might see a patient who has tended to run out of medications early, take more medication than have been prescribed by the physician, been non-compliant in attending any treatments that require proactive rehabilitation behavior (e.g., psychological pain management, biofeedback, etc.), and pursued invasive procedures that have initially been beneficial but ultimately fail such that more narcotic medication is requested. These types of behaviors, together with the psychosocial factors identified, support the diagnosis of a psychological opioid dependence (or addiction).
The closest DSM-IV diagnosis representing psychological opioid dependence as discussed in the pain research is opioid dependence (304.00). DSM-IV states that opioid dependence includes signs and symptoms that reflect use of opioid substances that either serves no legitimate medical purpose or, if a general medical condition is present that requires opioid treatment, are used in doses that are greatly in excess of the amount needed for pain relief (p. 248). AGGRESSIVE CONSERVATIVE TREATMENT
Gatchel’s (2004) model of physical and mental de-conditioning explains a patient’s transition from acute to chronic pain. Consistent with this model, treatment approaches involve physical and mental re-conditioning. When a chronic pain patient is involved in a multidisciplinary program, addressing both mental and physical elements are required for maximum success.
When the patient is involved in physical reactivation treatment, various cognitive factors must be successfully addressed. For instance, one key element will be helping the patient manage his or her fear of the pain, accepting the fact that hurt does not equal harm, and openly addressing issues that may be pressuring the patient into maintaining the sick role (and possibly sabotaging the physical therapy). This type of treatment will fall within the purview of the pain management clinician.
Aggressive conservative treatment should generally be preceded by a careful physical evaluation by the physician. This is done primarily to rule out any underlying serious condition that may need to be addressed and to develop the physical reconditioning program. An aggressive conservative treatment program will generally be designed by the supervising physician and implemented by a qualified physical therapist or exercise physiologist; although in many cases patients can simply be given a program of exercises and complete them on their own, independent of a formal treatment setting. There are several important aspects that must be attended to during the course of such a program. The following issues should be discussed with the chronic pain patient at the beginning of such treatment:
The Deconditioning Syndrome
As far as I can determine, the deconditioning or disuse syndrome was first characterized in 1984. Since that time it has received much attention in relation to back pain problems, other chronic pain disorders, as well as other illnesses. It has been generalized beyond chronic pain problems, and some feel it is related to "the base of much human ill-being."
The disuse syndrome is caused by physical inactivity and is fostered by our sedentary society. This disuse of our bodies leads to a deterioration of many body functions. This is basically an extension of the old adage "Use it or lose it." There are several physical consequences from disuse and deconditioning. These occur in many body systems, most notably those of the muscles and skeleton, cardiovascular, blood components, the gastrointestinal system, the endocrine systems, and the nervous system. For instance, consider the following:
Many other detrimental physiological changes also occur that are beyond the scope of this discussion. Disuse has been summarized as follows: "Inactivity plays a pervasive role in our lack of wellness. Disuse is physically, mentally, and spiritually debilitating." Many experts believe that the deconditioning/disuse syndrome is a key variable in the perpetuation of many chronic pain problems.
In summary the disuse or deconditioning syndrome can result in a myriad of significant medical problems and increase the likelihood of a chronic pain syndrome developing. Unfortunately, common attitudes and treatments in the medical community reinforce the fear patients have about their pain (and increasing movement) leading to passive treatment and deconditioning. The deconditioning syndrome can also lead to a variety of emotional changes that are associated with an increased perception of pain. The most ideal approach to managing the physical- and mental-deconditioning syndromes is to prevent their occurrence altogether. But even if the disuse syndrome has developed, the reconditioning approach is very effective if done appropriately. Completing physical reconditioning should be guided by appropriate behavioral principles. Physical Reconditioning
Fully participating in a reconditioning program, which includes strengthening, stretching, and aerobic exercise, is essential for maximum benefit. These programs may cause an initial increase in the patient’s pain, and that is to be expected. Also, passive modality-oriented therapies such
In chronic pain problems, it is most appropriate to exercise and physically recondition oneself using what has been termed the “quota system”. The quota system was first developed by a pain psychologist, Wilbert Fordyce, PhD at the University of Washington.
The quota method involves setting up an exercise regimen that progressively becomes more and more strenuous according to a fixed pattern rather than how the patient feels. For instance, a patient might start walking one-half block each day and then increase this by one block each week. With the quota system, the patient would complete these exercises according to the plan whether or not the pain was better or worse. In this approach the pain is essentially taken out of the equation, since the exercises are designed to be safe for a given chronic pain condition. It can be helpful to remind the patient that, “hurt does not equal harm”. Each time the quotas increase there may be a slight (and temporary) increase in pain due to the reconditioning (not injury). The quota-system approach has been shown to be very effective in university pain program settings. Unfortunately, it is used much less frequently in routine physical therapy practice. The quota system will be discussed in more detail subsequently.
PRINCIPLES FOR A CHRONIC PAIN RECONDITIONING PROGRAM
The following sections discuss how to approach a conditioning program in the treatment of chronic pain. The general principles include using the quota system, having an aerobic component to the program, and making sure that family and friends support the patient in a proper manner. A multidisciplinary pain program with reconditioning also includes cognitive behavioral therapy and medication management (often with detoxification) as discussed previously. The Quota System
As mentioned previously, the quota system is a specialized approach to exercising (or to any activity for that manner) that involves working to a specific quota rather than being guided by the pain. It is important that this be done initially under the supervision of a physician and qualified physical therapist. The quota system can be applied for any type of exercise or activity that the patient wishes to increase. In setting up a quota system for an exercise program the patient starts with what are called baseline measurements. In developing a baseline the patient exercises until pain or fatigue stops him or her over three consecutive sessions. An example of this might be doing repetitions of a strengthening exercise. The patient may only be able to do four repetitions on the first session, six repetitions on the second session, and five repetitions on the third session. Once the three baseline measures are taken, an average is then determined. In the example above, the average would be five repetitions for the particular exercise (4 6 5 = 15, divided by 3 = 5).
The initial quota is then set at 70 percent of the baseline average. Therefore the patient would begin the program for this particular exercise at an initial quota of three repetitions (70 percent of 4 = 2.8, and round off to the next highest number). Setting the initial quota at 70 percent of the baseline average ensures that the patient will be successful in meeting the quota. Once the initial quota is established, the patient is instructed to do that number of repetitions regardless of the pain. The same type of quota can be set for such diverse things as walking distance, swimming distance, amount of time on a stationary bicycle, and any exercise that involves repetitions. A baseline measure is always taken over three or four sessions and then 70 percent of the average constitutes the initial quota.
It is helpful for patients to chart their progress for each exercise. The x-axis can be labeled “exercise session number” and the y-axis is the number of repetitions (or other exercise variable) required to meet the quota. This gives a visual record of progress as well as the quota that is required for the specific exercise session. It is also helpful to chart the "target" value (the quota) and the "actual" amount of repetitions for each exercise session. These are used to document the patient’s quota target for the exercise and the actual amount of the exercise done for that session.
The quota system forces a patient to exercise to a certain, safe level while removing pain from the treatment equation. In addition, the quota system forces the patient to use proper pacing techniques. If patients are allowed to exercise depending upon how they are feeling that particular day, one often sees progress values that are very inconsistent. On a “good” day when the patient is in less pain, he or she will “go for it” and do much more than is recommended. Of course, most of the time, this results in a severe flare up in symptoms causing the patient to miss subsequent exercise sessions and regress to a lower quota value upon returning. This pattern (over-doing exercises, exacerbation in symptoms, and “crashing”) is very frustrating for the patient and can lead to a treatment dropout.
A question that must always be dealt with is how rapidly to increase the quotas. This is usually determined by the supervising physician or physical therapist and will depend on the type of exercise as well as the chronic pain problem. In addition the therapist will take into account how physically deconditioned the patient has become. Pacing
The concept of pacing is built into the quota system of exercise. Pacing is a technique for approaching any activity such that the chronic pain is kept under reasonable control. Pacing involves a gradual increase in activity according to a systematic plan. This approach can be used for exercise as well as any other activity. For instance it might also involve doing some activity and then taking regular breaks throughout the day to prevent acute exacerbations of the pain.
As discussed previously, a common pattern seen in people with chronic pain is the "overdo and crash" pattern, whereby the patient begins a day with minimal pain and subsequently engages in so many activities that he or she is literally in bed with pain for the two or three days following. This pattern may then continue such that the patient is continually overdoing activities when he or she begins to feel good and then "crashing" for several days thereafter. This is an unhealthy approach to pain rehabilitation and should be replaced with a "pacing" format. Pacing should not be confused with the concept of "being guided by the pain." Pacing encourages a reasonable amount of activity and exercise, not more and not less. The patient must attempt to do activities and exercise each day while pacing him- or herself.
Aerobic Conditioning
One component of a good exercise program for chronic pain should be aerobic conditioning. This should also initially be supervised by a physician or qualified physical therapist. Aerobic conditioning exercises are those that result in an increase in the uptake and utilization of oxygen. Actual aerobic conditioning occurs when the heart rate reaches a certain level and is maintained at that level for a specific period of time. A rough estimate of a person’s target heart rate for aerobic conditioning is the following: Subtract your age from 220 and then take 70 percent of the resulting number. The following formula represents this equation for a forty-five-year-old person: 220 - 45 = 175, then 70 percent of 175 = 123 (the target heart rate rounded off to the nearest whole number).
The quota system can be used for aerobic conditioning as well. First the patient must choose one or more aerobic conditioning exercises under the supervision of his or her physician. This might include such activities as brisk walking, swimming, or a stationary bike. The baseline is established by doing the exercise until the patient must stop due to increased pain or fatigue. The patient should be reminded that he or she should not attempt to "push it" when the baseline is being established. After doing three or four sessions of a baseline take the average and multiply this by 70 percent. This will give you a beginning quota for the aerobic conditioning program. For instance if the patient can initially do an average of ten minutes on the stationary bicycle, then the initial quota would be seven minutes to start. A typical quota system for this type of exercise would be to start at seven minutes twice per day and increase the bicycle sessions by one minute every fourth session. This quota system will gradually increase the patient’s tolerance on the bicycle and increase the amount of aerobic conditioning that he or she is able to obtain. This could be done until the patient has reached a reasonable goal, which might be getting to a target heart rate for twenty minutes on the stationary bicycle three times per week. A similar system should be set up for other aerobic conditioning exercises, such as swimming and brisk walking.
Aerobic conditioning is an important part of a chronic pain rehabilitation program, not only for its conditioning component but also to help decrease stress, increase the fluidity of movements, and decrease the overall pain.
Family, Friends, and Exercise
The last aspect of an exercise program is the patient’s psychosocial environment, which includes family, friends, and work associates. The psychosocial environment is an important element in any chronic pain rehabilitation program. Consider the following case example, which is not uncommon in patients with chronic back pain:
In this situation the patient's family and friends misunderstood her back pain problem and the importance of the rehabilitation approach. The patient was instructed to educate them as to the importance of a quota-system-based increase in exercise and activity. She was also instructed to give them specific guidelines not to respond to her pain behaviors and to encourage her for any increase in activity that was observed. This example underscores that guidelines are needed in terms of dealing with family and friends when embarking on an exercise program or increasing one's activities. Specific guidelines are as follows:
SPINAL CORD STIMULATION (SCS)
Overview
Spinal cord stimulation is a reversible pain treatment that utilizes low-voltage electrical pulses (termed “neuromodulation”) to manage chronic, intractable neuropathic pain. It is based upon the gate control theory of pain as discussed in the course, Chronic Pain Management I: Concepts. Consistent with the gate control theory of pain, spinal cord stimulation attempts to “override” a pain signal with another type of sensation. In fact, the golden rule of spinal cord stimulation is that stimulation-induced paresthesias must cover the painful area for effective pain relief.
Neuropathic pain is a specific type of pain that is initiated by damage to, or dysfunction of, the nervous system. In some cases, actual nerve damage is not always identifiable even though the neurologic symptoms are present. Neuropathic pain is often described as burning or shooting. Neuropathic pain can be extremely difficult to manage and a certain proportion of patients fail to respond to medication and other pain management treatments. These patients are the target population for spinal cord stimulation.
Spinal cord stimulation involves a trial period during which the intervention is attempted for five to seven days without permanent implantation. Based upon the results of the trial period, permanent implantation may be recommended. Research has demonstrated that psychological factors are powerful predictors of a patient’s long term response to spinal cord stimulation. Therefore, pre-implant psychological screening is recommended by the evidenced-based literature. In fact, it is required by Medicare and most insurance carriers as a condition for undergoing the pre-SCS trial. As such, the pain practitioner or behavioral health specialist is intimately involved in the spinal cord stimulation treatment process. MEDICAL CONDITIONS ASSOCIATED WITH NEUROPATHIC PAIN
Spinal cord stimulation is often considered as a pain management treatment in the following conditions:
Of these medical conditions, the most common are failed back surgery syndrome, complex regional pain syndrome, and postherpetic neuralgia.
Failed back surgery syndrome is a general term to describe patients who are left with back and/or leg pain after spine surgery. In general, spinal cord stimulation may be suitable for patients with radiating leg pain greater than back pain (or arm pain after cervical spine surgery). Studies suggest that between 15% and 40% of patients will have chronic back and/or leg pain after lumbar spine surgery.
Complex regional pain syndrome is a neuropathic pain condition that is not well understood. Diagnostic criteria include the following:
Treatment of complex regional pain syndrome (CRPS) most often involves managing the pain while physical therapy targeting restoration of function is completed. In the early stages, controlling the pain may include stellate ganglion blocks and medications. As the condition becomes chronic, psychological treatment focusing on quality of life and other issues, as well as spinal cord stimulation, are often indicated. CRPS affects the upper extremity 44% to 61% of the time and the lower extremity 39% to 61% of the time.
Postherpetic neuralgia can occur after an outbreak of the herpes zoster virus. Herpes zoster is also known as shingles and is caused by a reactivation of the varicella zoster virus that has been latent since the primary infection (chicken pox). Initial treatments include antivirals, medications for neuropathic pain, and opioids. If not successful, spinal cord stimulation may be indicated. The lifetime risk of herpes zoster is 10% to 30% with the incidence increasing with age. Approximately 20% of those older than 50 years old will experience post herpetic neuralgia 6 months after the onset of herpes zoster rash.
THEORY OF SPINAL CORD STIMULATION
The concept of spinal cord stimulation was initially introduced by Shealy and colleagues more than 40 years ago (Krames, 2002). It was based upon the gate control theory of pain developed by Melzack and Wall (1965). Spinal cord stimulation is thought to decrease the perception of pain by electrically stimulating the large diameter afferent nerve fibers in the dorsal columns of the spinal cord. This causes a tingling feeling (paresthesias) and inhibits transmission of the pain signal to the brain (by interrupting the neuronal signal flowing through the spinothalamic tracts). As such, the stimulation from the SCS overrides the pain signal traveling from the extremities to the brain and also replaces the pain sensation with one of tingling. SPINAL CORD STIMULATION COMPONENTS
A spinal cord stimulator device includes three implantable components. If permanent implantation is recommended, the entire system is internal.
· A pulse generator · An extension cable (the wire connecting the lead to the generator) · A lead
The pulse generator. The pulse generator is the battery of the spinal cord stimulator that provides the low-voltage electrical pulses for stimulation. Certain aspects of the pulse generator are programmed by the physician including the amplitude, pulse width, and pulse rate. The amplitude is the strength of the electrical stimulation measured in volts which determines the level of tingling or paresthesias experienced by the patient over the painful area. The pulse width is measured in microseconds and determines the duration of the stimulation and how wide an area the paresthesias cover. The pulse rate is the number of electrical pulses per second measured in Hertz. Once the optimal parameters are determined by the pain management physician, the patient can control various parameters within the limits set by the physician. All of the control is done by remote control.
Prior to a few years ago, the pulse generator had a limited battery life and had to be replaced after approximately three to five years, depending on patient use. Of course, this necessitated additional surgery. Recently, rechargeable units have been developed and can last up to ten years, or more. Most of the units implanted currently are rechargeable units. Once the system is implanted, it is operated by the patient through the use of an external control unit (similar to a remote control). The system can be adjusted by the patient as well as turned off and on. The pulse generator is implanted under the skin either in the lower abdomen or buttock area.
The extension cable. The extension cable connects the pulse generator to the lead.
The lead. The lead is connected to the extension cable and includes the electrodes that deliver the electrical stimulation to the dorsal columns of the spinal cord. The lead is positioned in the epidural space on the posterior aspect of the spine. Lead placement is determined to maximize
There are two type of leads: percutaneous and paddle (also called neurosurgical) leads. The percutaneous leads are inserted through the skin using a large diameter needle and the paddle leads are inserted surgically using an open procedure. The percutaneous leads are round and inserted through a hollow needle (called a Tuohy). The Tuohy needle is first positioned (tunneled) to the desired location in the epidural space through the use of fluoroscopy (x-ray). The lead is then threaded through the Tuohy needle for placement. The advantage of a percutaneously lead is that it is less invasive and require less operating room time. The disadvantage is that, relative to surgically placed leads, there is a greater risk for “migration” or movement of the electrodes after placement. This can be a problem since lead placement is done based upon the patient’s report of pain relief and “coverage” of the painful area by the paresthesia sensation. If the lead moves (e.g. weeks after placement) the pain control might be lost requiring another surgery. Also, percutaneous leads generally have less favorable stimulation characteristics.
Surgically placed leads are placed through a small laminotomy/laminectomy (removal of part of the lamina of the vertebra). This procedure requires that a neurosurgeon or orthopedic surgeon be involved and is more extensive than placement of the percutaneous lead. PHASES OF SPINAL CORD STIMULATION
The phases of a spinal cord stimulation intervention can be seen in the Figure. The behavioral health practitioner is an important participant in this process.
Psychological Screening Evaluation
As discussed in the Bala, Riemsma, Nixon and Kleijnen (2006) review of the literature, spinal cord stimulation is part of an overall treatment strategy and is used only after the more conservative treatments have failed. The authors go on to discuss that “a thorough psychological assessment and trial stimulation is required prior to permanent implantation of the device.” The pre-trial and implant psychological screening is required by Medicare as well as other insurance carriers. Pre-implant psychological screening is recommended (or required) since psychological factors have been found to be predictive of long term success. These predictor variables and suggestions for a pre-screening psychological assessment battery will be discussed subsequently in greater deal. SCS TEST STIMULATION PHASE
If the patient “passes” the psychological screening, the spinal cord stimulation test phase is undertaken. The spinal cord stimulation test phase generally involves placing temporary percutaneous leads with an external pulse generator to help determine whether the patient is a candidate for a permanent implantation. The test phase allows the patient to utilize the spinal cord stimulation system for between five and seven days.
The SCS test stimulation phase begins with percutaneous placement of the temporary leads. These are connected to a temporary external pulse generator. This procedure is often done in an outpatient surgery center. To complete the lead insertion and placement, the patient is sedated, but not unconscious. The placement of the temporary leads takes between 45 minutes and two hours. To correctly position the electrode leads, the spinal cord stimulator pulse generator is activated during the procedure and the patient assists in guiding electrode lead placement. The patient will tell the physician when he or she is feeling the paresthesia and whether or not it is “covering” the painful area. Once the temporary system is in place, the patient can utilize it over the next five to seven days. During this time, the stimulation parameters can be changed to optimize pain control. The spinal cord stimulation trial allows the patient to determine whether permanent implantation is a reasonable course of action. In clinical practice and in the research literature, successful test phase stimulation is defined as at least 50% reduction in pain. Most often in a clinical setting, the patient will return to the physician after the trial phase and simply be asked one question, “did you obtain 50% or better pain relief during the trial?” Based upon the patient’s answer to this single question, permanent implantation may or may not be recommended. From a biopsychosocial standpoint, there are several problems with this approach in terms of predicting long term response to the spinal cord stimulation intervention. These are as follows:
Memory for pain is notoriously inaccurate. Even so, the patient is being asked to summarize seven days of trial use of the spinal cord stimulator by answering a single question. One can imagine that if the patient happened to have a “good day” just prior to the follow-up visit, while having six prior days of no response to the spinal cord stimulator unit, the answer to this follow-up question might be “yes.”
Determining actual pain relief. The criteria of greater than 50% pain relief as determination for permanent implantation does not take into account other variables that are important to long term chronic pain management. These include, but are not limited to: an increase in overall function including activities of daily living (ADL’s), a decrease in the use of pain medication, improvement in mood, improvement in the patient’s quality of sleep, etc. Certainly, if an intervention is to be determined “successful” in terms of chronic pain management, all of these variables should be impacted in some way.
Patient honesty about the trial results. Some research has indicated that the small percentage of patients may not be truthful in discussing their actual response to the spinal cord stimulator trial. These patients believe that the permanently implanted unit will somehow be “stronger” or more effective than the trial unit. Therefore, even though they have had an inadequate response, they will tell the physician that they did receive greater than 50% pain relief in order to obtain the permanent spine cord stimulation system. Not surprisingly, they will then request that the unit be removed within the following year due to lack of efficacy.
Placebo and expectancy effects. Asking the patient about his or her response to the spinal cord stimulation trial does not take into account expectancy or placebo effects. Again, the placebo response is well documented in various treatment approaches. Since spinal cord stimulation is often considered an “end stage” treatment, patients’ expectations for success are very high. Therefore, one might assume that strong factors are operating to support the expectancy and placebo effect.
As will be discussed subsequently, there are methods that can be used to enhance the predicted validity of the spinal cord stimulator trial. Unfortunately, these are rarely used in clinical practice even though they are well-researched. This is an area where the behavioral health practitioner can have a significant impact.
PERMANENT IMPLANTATION PHASE
If the SCS stimulation trial is determined to be successful, permanent implantation can proceed. As previously discussed, there are two types of leads: percutaneous leads and neurosurgical leads. The percutaneous leads are almost always used during the spinal cord stimulator trial. They are also the most common type of lead used for permanent implantation. The neurosurgical leads require a partial laminectomy (removal of part of the lamina) and this must be done by a neurosurgeon or orthopedic spine surgeon. Clearly, the percutaneous leads are less invasive. The patient should understand what type of procedure is recommended relative to permanent lead placement.
During the permanent implantation procedure, the lead is again placed to maximize “coverage” of the painful area. Again, this does not remove the pain, but simply “overrides it” or “covers it” with another sensation. This sensation is described as a paresthesia or “tingling sensation.” The patient should have a good understanding that this is the purpose and desired outcome of spinal cord stimulation treatment and that it is not designed to “take the pain away.” Some patients find the paresthesia sensation uncomfortable and intolerable. This should be quickly identified during the trial phase. In many cases, the lead that was used during the trial phase is retained and simply anchored to the interspinous ligament. The lead is then connected with the extension wire to the pulse generator. Again, if the lead is actually replaced, the patient is conscious during the procedure in order to assure proper placement.
Once final placement is assured, the lead is connected to the pulse generator by the extension wire. This is completely internal and the extension cable is tunneled under the skin. The pulse generator is implanted just under the skin either in the abdomen or upper buttock area. The insertion of the permanent lead and implantation of the pulse generator takes approximately two to three hours and is generally done on an outpatient basis. An important, but often overlooked issue is placement of the pulse generator. For instance, if the patient generally sleeps on his or her right side, the generator should be placed on the left side. Also, placing the generator near the belt line should be avoided. The behavioral health practitioner can help insure that the patient addresses these issues with his or her pain physician.
After permanent implantation, the patient will follow-up to adjust stimulation parameters and assess pain control. The frequency of visits during the first year is dependent on physician preference. Once adequate pain control is established, the frequency of follow-up visits is faded. Combining cognitive behavioral pain management treatment with spinal cord stimulation can enhance treatment outcomes. COMPLICATIONS ASSOCIATED WITH SPINAL CORD STIMULATION
Complications are rare and can be divided into procedural complications and technical failures. Procedural complications include wound infection, cerebrospinal fluid leaks, dural puncture headaches, and the inability to thread the lead percutaneously into the epidural space. Technical failures include lead migration and fracturing, unwanted stimulation, inadequate paresthesia coverage, and pain over the pulse generator battery implantation site. According to the Health Technology Literature Review (2005) technical and procedural complications are as follows (most frequent to least frequent):
· Lead migration · Lead breakage · Infection · Hardware malfunction · Unwanted stimulation · Hematoma · Paralysis · Cerebrospinal fluid leak · Pain over the implant · Allergic reaction · Skin erosion · Loose connection · Battery failure · Other Contraindications to Spinal Cord Stimulation
Contraindications to spinal cord stimulation treatment currently include the following:
PRE-IMPLANT PSYCHOLOGICAL SCREENING
Purpose: Why is it so Important?
The long term success of spinal cord stimulation is somewhat disappointing. As discussed by Beltrutti et al. (2004) in an extensive review of the literature, “it is known that, in spite of meeting appropriate clinical criteria for spinal cord stimulation (SCS) and having undergone flawless procedures, a significant number of patients who fail the therapy continue to exist” (page 204). Beltrutti et al. (2004) go on to state that: “to improve treatment outcomes of SCS, seems to be essential to perform psychosocial evaluations on all persons clinically indicated for SCS to exclude those patients, who most probably, on a psychosocial level, will fail the procedure” (page 205). As discussed by Doleys (2006), “however, reviews of the literature have indicated a reported loss of pain relief in up to 50% of patients at one to two years post-implantation, despite a successful trial period of stimulation” (page 1). Doleys goes on to state that “in one study, 100% of patients reported success at 16 months, but only 59% still had these results at 58 months. Psychological factors may play an important role in understanding this apparent loss of efficacy, particularly in the case of a technically adequate implant” (page 1). As Doleys discusses, “if a failure rate of 25-50% in patients who had previously undergone trials and implantation of SCS devices is unacceptable, then an examination of psychological variables is required” (page 1). Of course, this failure rate is not acceptable and increasing success rates is certainly appropriate.
As discussed by Doleys (2006), the use of spinal cord stimulation for chronic pain control is increasing and this is likely due to several factors: First, “many pain management physicians feel that attempting a spinal cord stimulator trial is reasonable in virtually all cases since the procedure is entirely reversible and with minimal risk. Second, “the economic considerations and the reinforcement of being known as a surgeon with experience in these types of implantations cannot be overlooked” (page 2). As such, there is often a discrepancy between a given practitioner’s reported outcomes and the evidenced-based literature. As discussed by Doleys (2006, page 2), it appears that the more experienced, published, and outcome-oriented practitioners, although enthusiastic about SCS therapy, are more conservative in their predictions related to outcome. Third, the presence of high profile personalities such as Mr. Jerry Lewis reporting successful results to spinal cord stimulation has clearly heightened the public awareness of SCS therapy. This type of publicity has also, without a doubt, increased patient’s expectations regarding the potential benefits of SCS therapy. In fact, Jerry Lewis is so enthusiastic about his response to SCS that many patients will have unrealistic expectations about their likely individual response to this intervention. Lastly, manufacturers of SCS systems aggressively market to the public directly which can further enhance unrealistic expectations.
Given all of these factors, SCS procedures are being recommended more frequently. In addition, patients (and many pain management physicians) are resistant and defensive relative to the issue of pre-implant psychological screening. As suggested by Doleys, the only reason that pre-implant psychological screening is often completed is the fact that it is required by Medicare, many private insurance carriers, and suggested in many evidenced based practice guidelines. Without these requirements, pre-implant psychological screening would likely be done on a very infrequent basis.
Poor patient selection, preparation and management are more likely causes of unsatisfactory long-term response to implantable pain control systems than are technical failure or device complication (Doleys, 2002). Pretrial patient screening seeks to avoid “false-positives” (those implanted that have a poor outcome) and “false-negatives” (screening out those patients who would have benefited from the procedure). The goals of SCS and pre-pump screening, and patient benefits have been summarized by Williams (1996) as:
· Identifying those patients most likely to benefit from SCS/intrathecal pump
· Preventing candidates from undergoing an invasive and costly procedure with poor prognosis for relieving pain
· Aligning rejected candidates with more appropriate alternative treatment
Determining a patient’s suitability as a trial candidate depends upon an appropriate assessment of medical, psychological, and behavioral factors. As discussed at length by Doleys (2002), a “positive response” to a pre-implant trial is inadequate to predict a favorable outcome to permanent implantation (page 339):
COMPONENTS OF THE PRE-IMPLANT BIOPSYCHOSOCIAL SCREENING
As discussed in the literature, the pre-implant screening should include the following:
· a comprehensive clinical interview · appropriate psychological test battery · review of available medical records
As long as the testing battery validly assesses the predictor variables, there is flexibility relative to the choice of individual instruments. Certainly, the testing instruments should include those with validity scales and have been validated for use with a chronic pain patient population. In addition, the test instruments should have some research supporting their predictive validity relative to pre-implant and spine surgery outcome. A review of various instruments used for this purpose can be found in the second course, Introduction to Chronic Pain Management II: Assessment and Treatment. Examples of some of these instruments will be presented shortly.
Presenting the Pre-Implant Screening to the Patient
As with any psychological evaluation, eliciting the patient’s cooperation is essential. This can be more challenging when performing a psychological evaluation of a medical patient. Explaining the nature and purpose of the pre-implant screening to the patient should be done at the outset of the clinical interview. The guiding philosophy is that the evaluator is attempting to help the patient find the best treatment possible for the chronic pain and avoid any unnecessary, invasive procedures that have a high likelihood of failure. In some cases, the behavioral health practitioner must overcome the pain management physician’s communication to the patient that the pre-implant screening is not “really” necessary, but is required by the insurance company. In addition, the pain management physician will occasionally communicate to the patient that the pre-implant screening is simply to determine whether the “pain is in your head” and/or “whether you are crazy.” If this type of communication has occurred, the behavioral health practitioner will have a challenging task in terms of eliciting the patient’s cooperation and managing defensiveness. In these situations, the patient has the idea that the behavioral health practitioner will attempt to “withhold” a treatment that can help him or her and, that the practitioner is somehow acting as “an agent of the insurance company.” In these cases, the patient attitude is one of potentially being “screened out” simply for the insurance company to save money. If the behavioral health practitioner senses any of these patient attitudes, they should be addressed and managed in the initial stages of the clinical interview.
I will often begin the clinical interview by asking the patient what he or she has been told by her pain management physician relative to the purpose of the pre-implant screening. I will also question the patient about his or her understanding of the proposed procedure. I discuss with the patient that the purpose of the screening is to determine whether the patient has a reasonable chance for clinical success. I then explain the difference between “technical success” versus “clinical” success or failure. I present the idea to the patient that he or she certainly “does not want to undergo another surgery if there is no potential for benefit.” I discuss that if he or she is found not to be a reasonable candidate for the spinal cord stimulator trial, alternative treatments that have a higher likelihood of success will be recommended. Again, even though this is often a one time evaluation, elicitation of patient cooperation and trust is very essential to help achieve valid results.
Clinical Interview and Review of Medical Records
The clinical interview components are very similar to those of a chronic pain assessment. For any behavioral health practitioner who works with chronic pain patients, the components of the pre-implant clinical interview will be quite familiar. Aspects of the clinical interview should include at least the following:
Identifying Information
Presenting Problem and Review of Available Medical Records
Current Symptoms and Level of Function
Work History
Other Medical Problems and History
History of Injuries
Interviewer Observations and Mental Status Examination
Psychosocial Situation
Psychiatric Treatment History
Substance Use and History
Medications
Understanding of the Proposed SCS Treatment
I find that the review of medical records is very useful if they can be obtained. Often, the medical records information is quite discrepant from the history as provided by the patient. The medical records can provide clues about response to previous treatments, the patient’s motivation toward improvement, and presence of “red flags” such as doctor shopping and medication overuse.
Pre-Implant Pain and Psychological Testing Battery
As discussed previously, there is some flexibility in the choice of pain and psychological tests. Choice of tests should be guided by the following:
In many cases, there are no studies specifically addressing the predictive validity of a psychological test to predict outcome relative to a spinal cord stimulator or drug delivery system (“pain pump”). Therefore, results might be extrapolated from research investigating psychological testing and spine surgery outcome.
Some of the more comprehensive tests that include validity scales, and have been validated for the use on a chronic pain patient population include the MMPI-2, the Millon Behavioral Medicine Diagnostic, and the Battery For Health Improvement-2. Aside from these comprehensive instruments that contain validity scales, other tests might be utilized that are especially appropriate to a chronic pain population such as measures of depression, anxiety, coping skills, suicidality, locus of control, etc. The choice of these specific instruments will depend on the preferences of the practitioner.
In addition, tests that have been designed to directly assess pain-related issues are appropriate. These might include the Multi-Dimensional Pain Inventory (MPI), Chronic Pain Coping Inventory, Coping Strategies Questionnaire, McGill Pain Questionnaire, Oswestry Low Back Pain Disability Questionnaire, Survey of Pain Attitudes, Pain Self-Efficacy Scales, among others. Of course, one would not use all of these questionnaires. Rather, it is recommended to select one comprehensive test that includes validity scales along with more specific tests to assess other issues. SCS PRE-IMPLANT SCREENING CATEGORIES OF ASSESSMENT
According to the evidenced-based research, Exclusionary and Cautionary factors have been established relative to pre-implant screening. I have modified these for my own use and the categories are listed as follows. In my assessments, I prefer to rate each of these factors along a continuum of negative, mild to moderately influential, or positive and significant. Based upon the data gathered, each of these areas should be easily evaluated.
PATIENT CATEGORIZATION:A “SCORECARD” APPROACH
There are no hard and fast rules regarding screening decisions. The decision is based upon clinician judgment and the objective test data. The use of a “scorecard” type of system can aid the clinician in making a decision relative to pre-implant screening results. This also provides some objectivity and consistency in determining appropriateness for SCS treatment across patients. Lastly, it adds objectivity to the assessment and demonstrates a knowledge of the evidence-based research in this area.
A categorization system developed by Heckler, et al. (2007) and others is helpful in conceptualizing pre-implant screening results. The categorization system places patients in one of four categories as follows:
ENHANCING THE VALIDITY OF THE PRE-IMPLANT TRIAL
As discussed previously, there are several factors that can invalidate the results of the pre-implant trial even in the properly psychologically screened patient. These include the patient’s inaccurate assessment of pain relief, lack of assessment of functional variables, not being truthful about true pain relief, and expectancy effects. The following pre-implant interventions can help increase the validity of the trial results. I will often schedule a follow up visit to discuss the results of the screening (after consultation with the referring physician) and ways in which the pre-implant trial results can be made more accurate for predicting outcome.
Even though a patient is found to be a reasonable candidate from a psychological perspective, he or she will often still have questions about the treatment approach. These questions can be discussed with the patient along with suggestions about how to get answers prior to the trial. I will discuss with patients that it is important that they get all of their questions answered prior to undergoing the trial. I have had more than one patient who was cleared psychologically decide against the SCS intervention after gathering more information (full informed consent).
As discussed previously, it has been demonstrated in the literature that a certain percentage of patients will purposely overestimate their response to the SCS trial in an effort to get the permanent implantation. The reason given is that they believe the permanent device will somehow be more powerful or effective than the SCS trial. I will go over these research findings and tell patients that they should be completely honest regarding the level of pain relief during the trial. I also tell them that the pain relief they obtain during the trial (or lack thereof) is what they can expect with permanent implantation.
I also warn patients about “expectancy” and “placebo” effects during the spinal cord stimulator trial. In order to help patients complete an objective assessment of their response to the spinal cord stimulator trial, I recommend that they keep a pain diary at least one or two weeks prior to the trial and continue it throughout the trial period. This helps patients assess their actual response to the spinal cord stimulator.
As discussed previously, one of the commonly overlooked areas in implantable pain therapies is adequate assessment during the trial period. As suggested by Doleys (2002) and others (see references), a more valid and effective approach is to monitor specific variables just before the trial and during the trial to gauge the actual impact of the intervention. Variables to be monitored might include pain ratings, function, medication intake, mood, quality of sleep, etc. The factors can be monitored very specifically through the use of a pain, medication and activity “diary”. These diaries have been used in chronic pain research and treatment for decades and simply involve having the patient keep pain ratings (e.g. 0-10 or VAS four times per day), medication consumption, mood (0-10), activity/function, etc.
SAMPLE EVALUATION REPORT FOR SCS SCREENING
The sample report that follows has been shortened and significantly edited and altered (presented in the most general manner) while preserving important relevant information for teaching purposes. This SCS screening evaluation was completed for medical-legal reasons. Although this type of screening evaluation may be more extensive than that required for private insurance carriers or Medicare, the principles are the same. I have chosen to present a complicated case that was not recommended to undergo SCS treatment. I believe using a “not cleared” example is more educational than a simple “cleared” evaluation. The actual psychological test results are included in the report for illustrative purposes. In this case, the pain management physician had attempted to complete the pre-implant psychological screening himself by using the Brief Battery for Health Improvement and interpreting it (with a decision to clear the patient). The insurance carrier did not accept this “clearance” since it was not independent and there was a clear conflict of interest.
Pre-Implant Screening and Pain Evaluation
Patient Name: Jane Smith Referring Physician: Dr. Algology Date of Evaluation: Some time in this century
Procedures Used:
Comprehensive Clinical Interview Pre-Implant Psychological Assessments of: Pain and Functional Ratings Patient Pain Drawing MMPI-2 Battery for Health Improvement-2 Pain Patient Questionnaire Multi Dimensional Pain Inventory Modified Somatic Perceptions Questionnaire Beck Depression Inventory-2 Review of Available Medical Records
Purpose of Consultation and Evaluation:
Medical records indicate the patient was referred to Dr. Algology for an independent medical evaluation. The IME is to determine the patient’s medical appropriateness for a spinal cord stimulator trial, as well as other issues. Prior to completing the IME, Dr. Algology requested that the patient undergo a lumbar MRI, EMG studies of the bilateral lower extremities, as well as pre-implant psychological screening.
Identifying Information:
This is a 46-year-old married female surgical nurse, who sustained an injury to her low back during the course of her employment.
Presenting Problem and Review of Available Medical Records:
The patient reported she sustained her injury during the course of her employment. At that time, she was working as a surgical nurse. The patient stated that on the date of the injury, she developed onset of lower back pain while helping a patient with a bed transfer.
Medical records indicate that initial treatment included physiotherapy, and medications (analgesics, muscle relaxants, and anti-inflammatories) without benefit. Due to her lack of response to the conservative intervention, an MRI of the lumbar spine was completed. This demonstrated a herniated disc at L5-S1 with the possibility of an extruded fragment. The patient was referred for neurosurgical consultation and an L5-S1 microdiskectomy was suggested.
The patient did not desire to pursue surgical intervention at that time. She subsequently sought additional medical opinions. Medical records indicate the patient underwent additional conservative treatments including three epidural injections. Unfortunately, these resulted in no improvement. Dr. Pulposus stated that the patient had failed conservative care and she should be reevaluated for possible surgical intervention.
The patient was evaluated by Dr. Facet, an orthopedic surgeon. He recommended a decompression laminectomy and diskectomy at L5-S1 with posterolateral fusion. The consultation report indicates the patient desired to proceed with surgery. In preparation for surgery, Dr. Facet recommended a weight loss program. The patient weighed 180 pounds at that time and was working on weight reduction in a self-guided fashion. Diagnoses included spinal instability, including retrolisthesis of L5-S1 with HNP.
Medical records indicate the patient underwent lumbar laminectomy and diskectomy, including posterior interbody fusion, at L5-S1. Post operative the patient was continuing on her Soma, Norco, and Vioxx. She was smoking .5 ppd of cigarettes per day. The patient denied any history of illicit drug use.
The patient was evaluated by Dr. Facet post-operatively and she was continuing to complain of her usual symptoms. Her x-rays demonstrated good fusion mass and the flexion-extension x-rays showed no instability. Recommendations included removing her lumbar brace and discontinuing the use of the bone stimulator. She was also instructed to start physical therapy. She was advised to continue on her usual medication regimen. She returned to see Dr. Facet and her symptomatic complaints were unchanged. She had been attending physical therapy and “is making progress.” She was continuing to rely on the Norco and Soma. By ten months postoperative she continued to complain of constant low back pain with constant radiation to the right lower extremity.
Months later, the patient “continues to be symptomatic.” It was suggested that she may have “instrumentation rejection” and she was recommended to undergo removal of the instrumentation. Medical records indicate the patient subsequently underwent removal of the instrumentation. The fusion was solid and the screws were not loose. Dr. Facet augmented the bone graft and did additional foraminotomies. Post-operatively her medications included Topamax (50 mg b.i.d.), Norco (5 tablets per day), Soma (5 tablets per day), and Celebrex.
The patient was requesting refills for her Norco and Soma. One year later, “the patient has continued to take large doses of medication.” She was advised to continue independent exercise within her tolerance. The patient was advised to follow-up in approximately one month.
The patient continued to complain of low back pain with radiation to the right leg. The patient was continued on her usual medication regimen. The patient followed up with her pain management physician. By that time, she was taking between 5 and 8 Norco per day and 5 to 8 Soma per day. The progress report indicates that her pain management physician was going to take over the medications. As such, they were refilled including Soma and Norco (up to 8 tablets per day each). In addition, the patient was started on Neurontin and the possibility of epidural injections discussed. Medical records indicate the patient then returned to see Dr. Facet. She was advised to continue with pain management under the care of Dr. Needle. The progress note on page two also states “she was provided with a refill for her prescription medication.”
Medical records indicate the patient was taking 8 Norco and 8 Soma per day to keep her pain from “unbearable levels.” She was now two years post her last spine surgery. The patient’s medications were refilled for a one month supply. The progress note indicates that Dr. Needle was recommending a spinal cord stimulator trial. The patient continued to follow up with her pain management physician while authorization for the SCS was pending. The note documents that “she is being maintained with both Norco and Soma, which seem to be working well for her. She is taking high doses, and today we discussed opiate medications and their addictive properties.” It also states that “after this discussion it was decided to continue to fill her medications of Norco and Soma, eight tabs a day.” She was scheduled to return to clinic in two months.
The patient returned to see Dr. Needle. The note indicates that she was continuing to use Norco (8 to 9 tablets per day), Soma (8 to 9 tablets per day), and Neurontin. She was given a refill on her medication regimen. The patient again followed-up with Dr. Needle. She presented “with the need for refills only.” She reported no change in her condition. She continued to rate her pain at a 7 out of 10 even with the high dose of medications.
The patient continued to follow up with Dr. Needle about every month. She continued to rate her pain at a seven out of ten primarily in the low back, but also in the right lower extremity. Numerous reports state that “she does not appear to be overly medicated.” The patient’s medications continue to include Norco (10 per day), Soma (10 per day), and Neurontin.
The patient returned to see Dr. Needle for a follow-up pain management consultation. The reevaluation was for consideration of a trial of spinal cord stimulation. The progress note states that “she does not appear to be overly medicated.” Dr. Needle did complete “psychologic screening” including the BBHI-2. He felt that the results indicated she could appropriately participate in the medical care and procedures proposed (e.g. the spinal cord stimulator trial). The progress note indicates that the patient’s medications were reviewed. She was prescribed Norco (10-12 per day), Soma (8 per day), and Neurontin (300 mg, six times per day).
The patient then followed-up with Dr. Needle and the patient was rating her pain at a nine out of ten. The patient’s medications were now Norco (12 per day), Soma (10 per day), and Neurontin. The patient was again prescribed refills including Norco (10 to 12 tablets per day), Soma (8 tablets per day), and Neurontin. She states that even on these high amounts of medication, she rates her pain at a 9 out of 10. The spinal cord stimulator trial was discussed.
Current Symptoms and Level of Function:
Currently, the patient complains of pain in the low back with radiation to the right buttock and down the posterior aspect of the right leg to the foot. She states that the pain is constant and rates it at 8.5 out of 10 “right now.”
The patient’s current typical day includes getting up at 7:00 a.m. with her 24-month-old son and bringing him into bed with her. She will rest in bed with her son until 9:30 a.m. at which time the two of them will get up. When she and her son get out of bed at 9:30 a.m., the patient will “wake up my 11-year-old daughter so she can make breakfast.” While her daughter is making breakfast, the patient will play with her son on the couch.
After breakfast, Ms. Smith will “set up my daughter with her home schooling task.” Her daughter is being home schooled through a charter school. The patient reported that after setting her daughter up with her home school activities, she will “lay on the couch” while her son plays. They will often go to the pool at 1:00 p.m., after lunch. The patient will put her son down for a nap at 2:00 p.m. The patient then takes more medication and takes a nap from approximately 2:00 p.m. until 4:00 or 4:30 p.m.
After her nap, the patient stated “I technically will make dinner.” She has gathered many “quick” recipes for dinner since she reported problems with that activity secondary to pain. Her husband will arrive home from work at approximately 6:00 p.m. The family will eat dinner, watch TV, bathe her son at 7:30 p.m., and retire to bed at 8:00 p.m. She and her husband will watch TV before falling asleep.
Work History:
Ms. Smith worked for the Mayberry hospital as a nurse for 5 years.
Other Medical Problems and History:
She denied any current medical problems, aside from her spine injury.
Interviewer Observations and Mental Status Examination:
The following is a summary of interviewer observation and a mini-mental status examination. A formal mental status examination was not necessary.
Attitude: The patient was very open and cooperative during the clinical interview. Pain Behaviors: Even though the patient rated her pain at 8.5 out of 10 during the course of the clinical interview, she did not display any pain behaviors. The patient remained seated throughout the entire clinical interview which lasted more than 90 minutes. Mood/Affect: The patient’s affect was fairly bright during the clinical interview. She was very talkative, responsive to questions, gesticulated with her upper extremities freely and smoothly, and would often smile or laugh while discussing certain aspects of her history. However, when discussing childhood history of abuse, she did become tearful. Her mood was described as quite variable depending on the situation. She will experience mood states of sadness, depression, happiness, irritability, and “feeling blessed.” She stated that “even though I hurt a lot, I am okay, I feel blessed.” Crying Spells: The patient reported periodic crying spells. She stated that “I cry easily.” Sleep: The patient reported that even though she will retire at 8:00 p.m., she is awake again after approximately one hour. She stated she has to “change positions constantly” throughout the night. She reported being “up and down” during the night. She stated her sleep is disrupted throughout the night necessitating daytime naps. Appetite and weight changes: The patient reported she has gained 100 pounds since the injury. At the time of the injury she stated she was 130 pounds and she is now 232 pounds. She has attempted to lose weight in the past as discussed in the review of medical records. Energy level: She stated “I do as much as I can,” especially having an 18-month-old son. Memory and concentration changes: Denied. Suicidal ideation, plan, previous attempts: Denied. Sexual functioning: The patient reported that her sex drive is “healthy.” She stated that she and her husband “maintain,” their sex life, but take care to not exacerbate her pain problem. Thought Process: The patient showed no evidence of a thought disorder. Orientation: The patient presented with a clear sensorium and was oriented in all spheres.
Psychosocial Situation:
The patient is 46-years-old and has been married for 4.5 years to her 46-year-old husband, who is a manager at a warehouse. The couple has an 24-month-old son. The patient was previously married and has an 11-year-old daughter from that marriage.
The patient has three sisters all of whom are in good health. The patient stated her father abandoned the family when she was 10-years-old and she has had no contact with him since.
The patient’s mother is 82-years-old, lives with the family, and suffers from Alzheimer’s disease. The patient and her family participate in the care of her mother.
The patient reported that since having her baby, she “pulled my 11-year-old daughter out of school to help with the baby.” That is the reason her daughter is now being home schooled. In addition, she stated her husband only works three to four days per week so that he can help at home.
Early Childhood History:
The patient reported a troubled childhood and adolescence. She began using marijuana as a young teenager. She started using cocaine and other drugs at 19-years-old. She was involved in drug use at least until the age of 21-years-old. She was incarcerated on more than one occasion as well as undergoing substance abuse and chemical dependency treatment. In addition, the patient reported being sexually abused as a young child.
Legal History:
As reported previously, the patient stated she was incarcerated on at least two occasions, once for 30 days and once for 60 days. Both of these incarcerations were related to drug possession and use. She stated that she did receive treatment for chemical dependency as part of these incarcerations.
Psychiatric Treatment History:
The patient reported she underwent “some counseling” approximately 1.5 years ago shortly after the birth of her son. She stated she only “went a couple of times” for postpartum depression. She denies any other psychiatric or psychological treatment history.
Substance Use:
The patient currently denies use of any illicit or recreational drugs. She does have a significant history for cocaine and possibly polydrug abuse. She was incarcerated and underwent chemical dependency treatment. The patient’s most recent drug use occurred approximately three years ago. She stated that in an effort to stop smoking cigarettes, she switched to smoking marijuana for approximately two months. She reported that although she found it difficult to stop smoking cigarettes, she did not find it difficult to stop smoking marijuana. Therefore, she switched from cigarettes to marijuana and then stopped smoking altogether. The patient currently denies the use of alcohol or cigarettes.
Medications:
The patient reported her current medications include Norco (12-14 pills per day), Soma (10-12 per day), Ibuprofen (t.i.d.), Gabatril (t.i.d.), and Gadapentin (q.i.d.).
Pain and Pre-Implant Assessments:
The pre-implant psychological test battery was constructed consistent with evidence-based guidelines (see North, Shipley et al., 2007; Beltrutti et al., 2004, for a review). The patient was administered the assessment instruments as listed previously. The following results were obtained:
Pain and Functional Ratings: On the Pain Patient Questionnaire, the patient rated her pain (0-10) at an 8.5 during the clinical interview. She stated the pain interferes with work, family chores, recreational activities, and sexual functioning 100% of the time. She stated she is in pain 100% of the time. Her pain is exacerbated by extended driving, sitting, standing, cooking, walking, bending over, and going upstairs. It is reduced by medication, rest, and the TENS unit.
Pain Drawing: On the Pain Drawing, the patient showed pain in the low back with radiation to the right buttock and down the posterior aspect of the right leg to the foot.
MMPI-2: The MMPI-2 is the most widely used psychometric instrument for presurgical and pre-implant screening prior to spine surgery. Numerous studies have demonstrated a relationship between MMPI-2 results and clinical outcomes to spine surgery (see Block, Gatchel, Deardorff, & Guyer, 2003 for a review). The results of the MMPI-2 are as follows:
Analysis of the consistency of item endorsement was evaluated using the decision rules developed by Greene (1991), Pope, Butcher, & Seelan (2000, 2006) and others (see references). There were no item omissions. The VRIN score (T=46) and the TRIN score (T=58F) were within acceptable limits. As such, it is determined that the patient responded to the items in a consistent fashion.
Analysis of the validity of the Profile was assessed using accepted standards (see Greene, 1991; Deardorff, 2000; Keller & Butcher, 1991; Pope et al., 2000, 2006). The validity scales including F, Fb, Fp, L, K, and S were determined to be within acceptable limits.
The patient demonstrated an elevation on the FBS Scale. The FBS Scale is the Fake-Bad Scale, which was originally developed by Lees-Haley, English and Glenn (1991) and has been the subject of extensive empirical scrutiny. The FBS was recently added to the standard scoring materials for the MMPI-2 after it was concluded that the empirical research established the utility of the scale in identifying potentially exaggerated claims of disability, primarily in the context of forensic neuropsychological evaluations. The panel of experts recommended that raw scores above 23 should raise concerns about the validity of self-reported symptoms and that raw scores above 28 should raise very significant concerns about the validity of self-reported symptoms (see the literature review by Ben-Porath & Telegen, 2007). The patient’s raw score on the FBS of 22 is just below the cutting score of 23, established by experts to raise concerns about the validity of the Clinical Profile. Overall, the Clinical Profile was judged to be valid and interpretable.
According to Fordyce and others (see references), patients with similar profiles present with a wide variety of vague and diffuse somatic complaints. These patients often show pain behaviors far beyond what would be expected due to nociceptive input and objective findings. In addition, these patients often show a low correlation between objective and subjective findings. These patients show a high readiness to emit pain behaviors with relatively low emotional distress. As such, illness behavior may not have a high response cost. In addition, as discussed by Fordyce, when evaluating chronic pain behaviors, one must always consider indicators bearing on how likely the person will be able to cope with being well. Patients with similar profiles had “difficulty coping with being well” and pain behaviors and disability are often reinforced by removing the patient from stressful responsibility demands (this is a “negative reinforcement” paradigm). This MMPI Profile, when found in a chronic pain population, is often associated with poor treatment outcomes, more severe or exaggerated pain ratings, dependency on medications, chronicity and greater disability (Beltrutti et al., 2004).
Although the patient did show an elevation on Scale 2 (Depression) on the Clinical Scales, analysis of the Harris-Lingoes Depression Sub-Scales indicate this was primarily due to endorsement of physical malfunctioning items rather than depressive symptoms. In addition, the patient did not show any elevation on the DEP Content Scale. This suggests a lowered level of distress associated with the chronic pain syndrome and that the patient may not be that uncomfortable in the sick role.
As discussed by Block, Gatchel, Deardorff, and Guyer (2003, page 83), elevations on Scales 1 and 3 reflect excessive sensitivity to pain rather than the cause of the pain. In other words, in the face of a certain level of nociception, individuals who have high scores on Scales 1 and 3 are more likely to experience high pain levels, and to be more functionally disabled than those with low scores on these scales. As such, pain sensitivity, as assessed by Scales 1 and 3, seems to predispose patients towards negative outcome to spine surgery and SCS (Block et al., 2003, page 84). Individuals with this profile tend to respond very poorly to interventional and invasive pain management techniques aimed at identifying and “fixing” a physical pain generator. The reason they do so poorly is that the other non-physical factors continue to impact their perception of pain and suffering.
Battery For Health Improvement-2: The BHI-2 is comprehensive self-report instrument designed for the psychosocial assessment of medical patients (Bruns & Disorbio, 2003). The purpose of the test is to provide assessment information and treatment recommendations for injured patients in a variety of settings. The scales of the BHI-2 have been found to correlate significantly with the MMPI-2. The BHI-2 assesses a number of areas relevant to the injured worker that are not assessed with the MMPI-2. The results of the BHI-2 are as follows:
The patient did not endorse any of the validity items. This reduces the risk that this profile was produced by random responding. There were no indications of bias responding, which supports the validity of the Clinical Scales.
As can be seen, the patient scored average for Somatic Complaints and Pain Complaints, while scoring moderately high on Functional Complaints. She scored low on Muscular Bracing. The patient did not show any elevation for Depression and scored low on Anxiety and Hostility. On the Character Scales, the patient did not show any elevations, but scored very low on Perseverance. Patients who score low on Perseverance may find the ordinary demands of life to be excessively difficult.
Multi-Dimensional Pain Inventory: This is a comprehensive self-report instrument that evaluates the impact of diverse chronic pain syndromes on multiple dimensions of a patient’s life (Turk and Melzak, 1992).
The T-scores for each scale are as follows:
On the MPI, the patient was placed in the Dysfunctional Cluster Classification Group. As can be seen, she scored approximately average for Pain Severity, above average for Interference With Functioning, below average for Life Control and below average for Affective Distress. She scored at or below average for all of the Activity Scales. These results are consistent with the MMPI and the BHI-2 in suggesting a relatively low level of Affective Distress associated with her chronic pain and disability. It also suggests a rather significant physical deactivation and deconditioning syndrome. The lower score on Life Control is consistent with her low score on Perseverance on the BHI-2.
Modified Somatic Perceptions Questionnaire: On the MSPQ, the patient scored an 11, which is in the moderate range of somatic anxiety and somatic focus.
Beck Depression Inventory-2: On the BDI-2, the patient scored a 25, which is in the moderate to severe range of self-rated depression. However, analysis of the individual items indicates a mildly dysphoric mood along with endorsement of cognitive distortions and physical symptoms. The BDI-2 is a very face valid instrument and the depression scores on the MMPI-2, BHI-2, and MPI are deemed to be more accurate.
SCS Decision-Making Rules:
Exclusionary Factors
Active Psychosis - Negative
Major Uncontrolled Depression and Anxiety - Negative
Unresolved Major Psychiatric Co-morbidity -Negative
Active Suicidal or Homicidal Behavior - Negative
Active and Untreated Substance Abuse Disorder - Positive
As discussed in this report, the patient does show a remote history of substance abuse and chemical dependency problems resulting in incarceration and treatment (one course of a 30 day treatment program and one course of a 60 day treatment program). The patient began using marijuana at an early age (approximately 13-years-old) and progressed to likely poly drug abuse from at least 19 through 21-years-old. Her last use of marijuana was approximately three years ago to help “stop smoking cigarettes.” Having a substance abuse or chemical dependency history does not, in and of itself, preclude one from a spinal cord stimulator trial. However, the detailed review of medical records, along with the psychometric testing and other data, suggest that the patient’s current use of high levels of Norco and Soma are more related to substance abuse issues than pain control.
The mixture of Norco and Soma is one of the most highly addictive combinations available. Research has consistently shown that carisoprodol (Soma) has a very high level of potential for abuse (see Toth & Urtis, 2004, for a review). In fact, carisoprodol was ranked 14 on a list of 20 of the most abused mood altering substances in the United States (Toth & Urtis, 2004). Part of the problem is that active metabolite of carisoprodol is meprobamate (previously marketed under the name Milltown). Meprobamate was used as an anxiolytic, but has a high abuse potential and significant drug interactions. The high abuse potential of carisoprodol was also found in another recent study (Owens et al., 2007) in which long term users of carisoprodol and other skeletal muscle relaxants were studied. It was found that patients using carisoprodol used concomitant opioids more frequently, more commonly had past diagnoses indicating other drug abuse, and continued to pay out of pocket for carisoprodol when third party coverage was discontinued. The authors conclude that “taken together these findings are consistent with published case reports suggesting the abuse potential of carisoprodol,” (page 2222).
The abuse potential of this medication combination taken by Ms. Smith is also exemplified by the fact that they actually have street names. Vicodin (or Norco) and Soma is referred to as a “Las Vegas cocktail,” while codeine and Soma is referred to as a “Soma-Coma.” The evidence-based research clearly indicates that for someone with a drug abuse history such as Ms. Smith, the use of a highly addictive combination of medications (Norco and Soma) is contraindicated. It also strongly suggests that, in the absence of significant objective physical findings, her acceleration of use of these medications was likely due to drug dependency issues rather than for pain management. The intensity of the patient’s drive to stay on the Norco and Soma is also underscored by the fact that she told Dr. Facet she had been cleared by her obstetrician to take the medication when, in fact, she had not. Therefore, by being deceptive, the patient took the medication for almost six months without medical clearance.
Lastly, relative to the use of Soma, in the case of this patient, I am not aware of any evidenced-based literature that supports the long term use of this type of muscle relaxant in chronic benign back pain cases. There are no studies supporting the efficacy of this medication beyond very short term use in acute back pain conditions or, possibly, very limited and short term use when a chronic back pain patient experiences an acute exacerbation.
The rationale behind prescribing these levels of Norco and Soma is not documented. It appears that the medications were being prescribed, and doses increased, based only on the patient’s subjective report of pain. It also appears that her physicians did not assess for a pre-morbid chemical dependency and substance abuse problem.
Serious Cognitive Deficits - Negative
Severe Sleep Disturbance - Severe
The patient did report rather severe sleep disturbance including awakening throughout the night. She states that the sleep disturbance is so bad she must take frequent naps during the day.
Somatization Disorder or Features -Negative
Involvement in Pain Related Litigation - Positive
It has been clearly established that in “study after study,” patients whose injuries place them in the workers’ compensation system have tended to have poor results from spine surgery (Block et al., 2003, page 65). This also applies to interventional techniques such as spinal cord stimulation. Again, this single variable is certainly not a preclusion for a spinal cord stimulator trial. However, it must be taken into account in conjunction with all of the other assessed variables.
Lack of Social Support - Negative.
Medication Seeking Behaviors and Deception - Positive
This category overlaps somewhat with the substance abuse issues discussed previously. If the medical records are accurate, it is clear that the patient has engaged in both medication seeking and deception. This occurred when she informed Dr. Facet that her obstetrician had cleared the Norco and Soma medication during pregnancy when, in fact, he had not. It appears deception also occurred associated with medication seeking when the patient was obtaining Norco and Soma from both Drs. Needle and Facet simultaneously.
Presence of a Major Chronic Pain Syndrome - Positive
This patient clearly shows a fully developed chronic pain and disability syndrome as outlined in this report. The multi-faceted nature of her chronic pain syndrome, along with its severity, is an exclusionary factor for spinal cord stimulation at this time. Although practitioners may cite multiple outcome studies documenting the efficacy of spinal cord stimulation treatment in the work injured population, these research groups are comprised of patients who have been screened out due to this type of co-morbid chronic pain syndrome.
Cautionary Factors:
Abnormal or Inconsistent Pain Ratings - Positive
During the course of the clinical interview, the patient rated her pain at an 8.5 out of 10 “currently.” Direct observation of the patient established that this pain rating was greatly exaggerated. As discussed in the body of this report, the patient did not display any significant pain behaviors during the course of the entire clinical interview. She also did not display any behaviors consistent with distress associated with a high intensity of pain. Although this might be explained as the patient being a stoic individual, but this was certainly not the case. The review of medical records documents many other instances in which she rated her pain at 9 out of 10, but the progress report also noted she appeared in “no acute distress.”
Certain Personality Disorders or Traits - Negative
Abnormal Psychological Test Findings - Positive
As discussed under pre-implant psychological test screening results, the patient did demonstrate consistent findings across the test battery. In essence, the results suggest that she is showing pain behaviors far beyond what would be expected due to nociceptive input and objective findings. The testing also indicated that she may not be that uncomfortable in the sick role and may find aspects of it reinforcing. This pattern of test results is predictive of a poor clinical response to SCS.
Invalid Concept of Pain or Pain Treatment - Positive
As with many chronic pain patients, there is often a “fix it” mentality and this is commonly supported by the medical community. The treatment philosophy is that if we fix the pain generator, the chronic pain syndrome will go away. In this case, a spinal cord stimulator may attempt to address the nociceptive input, but it would do nothing for the operant factors that are supporting her chronic pain behavior. As long as these operant factors are present, the spinal cord stimulator has no chance of success.
Inadequate Support from Spouse - Negative
Contrary to inadequate support from her spouse, the patient is receiving a great deal of attention and support from both her husband and 11 year old daughter. Although they likely feel they are helping the patient, they may be inadvertently reinforcing pain and disability behaviors. This will be discussed further under alternative treatments.
Inability to Manage the Implantable Device - Negative
Operant Factors Supporting Pain Behaviors - Positive
These findings were established by history, medical record review and testing. Operant factors include such things as positive reinforcement related to nurturing behaviors from her family, obtaining pain medications, and disability payments, along with negative reinforcement such as removing her from responsibility demands. It must be noted that these concepts are frequently misunderstood by the lay person. This does not represent malingering. Rather, these are operant factors that influence pain and disability behaviors out of the awareness of the patient.
Alternative Therapies With A Risk Benefit Ratio Comparable or Better Than SCS Remain To Be Tried - Positive
Although the physicians involved in this patient’s care assert that she has failed all conservative treatments and spinal cord stimulation is indicated as a result, this is not really true. The patient has never participated in a high quality multi-disciplinary pain rehabilitation program. An extensive number of outcome studies suggest that this is the treatment of choice for an injured worker with chronic pain, disability, medication dependency, and who is no longer a candidate for further invasive measures (e.g. spine surgery). A multi-disciplinary pain program with appropriate detoxification has essentially no risk associated with it and a high potential for significant benefit (a much higher probability of benefit versus spinal cord stimulation).
Pre-Implant Screening Results:
Two recent comprehensive review articles have established appropriate guidelines for pre-implant screening for spinal cord stimulation. These include “Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain” (North, Shipley, et al., 2007, Pain Medicine, 8, 200-275) and “Psychological assessment of candidates for spinal cord stimulation for chronic pain management: Expert panel report” (Betrutti, et al., 2004, Pain Practice, 4, 204-221). Based upon guidelines established in these extensive review articles, it is strongly recommended that this patient not be cleared to undergo spinal cord stimulation trial due to the high risk of clinical failure even if the procedure is technically done “perfect.” Summary and Recommendations:
SCS Screening Results. The patient was screened using established guidelines as outlined in two recent comprehensive reviews of the literature (Betrutti et al., 2004; North, Shipley, et al., 2007). Based upon these guidelines, it is strongly recommended that spinal cord stimulation be avoided due to the high risk of technical success but clinical failure. The data suggest the patient would obtain no benefit from SCS and that her current levels of medication use, pain complaints, and disability would be unchanged even after successful implantation.
Predictors for Poor Outcome for SCS. As discussed in this report, a myriad of exclusionary and cautionary factors were identified relative to the pre-implant screening. In summary, these include:
· Active and Untreated Substance Abuse Disorder. The detailed review of medical records, along with the psychometric testing and other data, suggest that the patient’s current use of high levels of Norco and Soma are more related to a substance abuse disorder rather than pain control. She has gradually accelerated from 3 Norco and 3 Soma per day just prior to her fusion to her current levels of 14 Norco and 12 Soma per day. She demonstrates significant drug-seeking behavior including deception.
· Medications from multiple sources. It appears that the patient was obtaining prescriptions from multiple sources for at least a year as documented in the medical records. At one point it appears she was receiving 5 Norco and 5 Soma per day from Dr. Facet while also obtaining a prescription for 8 Norco and 8 Soma per day from Dr. Needle.
· Using the medications during her pregnancy without medical clearance. Medical records indicate Dr. Facet instructed the patient to obtain clearance for the medication he was prescribing from her obstetrician. He continued to prescribe these medications from 1-2006 through 6-2006 under the impression she had obtained clearance when she had not. This suggests some deception on the part of the patient with the goal of staying on the medications.
· Using more medication than prescribed. According to medical records, Dr. Needle is currently prescribing 10-12 Norco per day and 8 Soma per day. Her actual use reported to me is 12-14 Norco per day and 10-12 Soma per day.
· Never assessed for substance abuse history. The patient is being maintained on significant amounts of Norco and Soma which is a highly addictive combination. However, there is no documentation that she was ever assessed for a history of a substance abuse or chemical dependency history by her treating doctors. Substance abuse history is a critical factor when utilizing long term opioid maintenance with chronic pain patients. It appears that this acceleration in medication doses was done simply based on the patient’s self report of pain.
· Never assessed for actual use of the medication. The medical records report high levels of medication use while the patient shows no signs of being over-medicated. Being on these levels of medication (especially the Soma) and not showing signs of over-medication can be due to one of two things: the patient has built a tolerance to the sedative effects of the medication or she is not using as much as is being prescribed. Recent research suggests that up to 30% of chronic back pain patients on long-term opioid maintenance therapy that present for treatment are actually disposing of their medications in another manner (e.g. giving them to friends or selling them).
· Severe sleep disturbance
· Involvement in pain-related litigation
· Abnormal and inconsistent pain ratings. During the course of the clinical interview, the patient rated her pain at an 8.5 out of 10 “currently.” Direct observation of the patient established that this pain rating was greatly exaggerated. The review of medical records documents many other instances in which she rated her pain at 9 out of 10, but the progress report also noted she appeared in “no acute distress.”
· Abnormal psychological test findings
· Invalid concept of pain or pain treatment
· Operant factors supporting pain behaviors
· Chronic pain syndrome. The patient demonstrates aspects of a fully developed chronic pain and disability syndrome. This includes such things as operant contributions to her level of pain behaviors and disability, significant medication-seeking behavior, being fully ensconced in the sick-role, showing significant physical deactivation and deconditioning, etc. This type of multi-faceted syndrome will not respond in any way to SCS. Rather, a multidisciplinary treatment intervention that can address all aspects of the chronic pain syndrome simultaneously in a coordinated fashion is indicated.
Alternative treatment with a better risk-benefit ratio. According to Williams (1996), as discussed previously, one of the purposes of a pre-implant psychological screening is “aligning rejected candidates with more appropriate alternative treatment.” Since this patient has clearly been shown to be a poor candidate for spinal cord stimulator implantation from a psychological perspective, suggestions for alternative treatments are appropriate. In fact, there is an alternative conservative treatment that has a much higher likelihood of success with a very low level of risk (a much better risk-benefit ratio than SCS). I would suggest that the patient is appropriate for a multi-disciplinary pain rehabilitation program including services delivered in an integrated fashion:
(a) physical treatment such as functional restoration and reactivation, (b) appropriate medical care and supervision, (c) psychological and behavioral care, (d) psychosocial and family interventions, (e) vocational rehabilitation and training, (f) education, and (g) medication detoxification.
A multi-disciplinary pain program with appropriate detoxification has essentially no risk associated with it and a high potential for significant benefit (a much higher probability of benefit versus spinal cord stimulation). Extensive reviews of the treatment outcome research on multi-disciplinary pain programs suggest they are the most effective way to treat a chronic pain and disability problem as experienced by Ms. Smith (See references). Given the amount of medication this patient is currently taking, she may require a brief initial inpatient stay for detoxification followed by an outpatient day treatment program.
The goals of this type of program would include providing her with non-medicine and non-invasive techniques for managing her chronic pain, tapering her completely off of her addictive medications (Soma and Norco), changing the reinforcement factors that are currently supporting pain and illness behavior, having her complete a physical reactivation program to reverse the physical deconditioning syndrome, stabilizing her sleep-wake cycle, and attempting to return to some type of gainful employment. Of course, these types of programs depend greatly on a patient’s motivation to pursue this type of approach. The patient would need to commit to making a philosophical shift from “being fixed” to learning techniques to overcome her chronic pain and disability while improving her quality of life. If she can make this commitment, she and her family will benefit greatly.
The results of this evaluation will be taken into account by Dr. Algology as part of his comprehensive IME evaluation. He will ultimately decide whether the spinal cord stimulator trial is reasonable from a medical standpoint, taking into account the psychological and psychosocial findings. If he feels the patient might benefit from a multi-disciplinary pain rehabilitation program, I would be happy to suggest one or two programs with which I am familiar.
WILLIAM W. DEARDORFF, PH.D., ABPP Fellow, American Psychological Association DIPLOMATE, AMERICAN BOARD OF HEALTH PSYCHOLOGY ASSISTANT CLINICAL PROFESSOR, UCLA SCHOOL OF MEDICINE FELLOW, AMERICAN ACADEMY OF CLINICAL HEALTH PSYCHOLOGY
CONCLUSIONS
As we have reviewed in this course, the pain management clinician should be intimately involved in the management of the chronic pain patient when certain issues are present: complex medication decisions, physical deconditioning and the need for reactivation, and special procedures (SCS). The evaluation and treatment of chronic pain patients relative to these “special issues” cannot be done outside of a multidisciplinary context. The behavioral health practitioner must have a close and collegial working relationship with the other healthcare providers. In addition, for these special types of treatments to be successful, these other providers must be respectful of what behavioral health has to offer in terms of applying psychosocial principles to medical care and treatment. I have found that physicians are often skeptical of what behavioral health has to offer initially but become convinced over time when the usefulness of these evaluation and intervention procedures is demonstrated. Frequent and efficient communication with the physician is essential and it is important for the behavioral health clinical to be proactive in developing a role in the patient’s care.
RESOURCES
The following books are excellent resources for any who works with chronic pain patients.
Belar, C.D. and Deardorff, W.W. (2008). Clinical Health Psychology in Medical settings: A Practitioner's Guidebook, Washington, D.C.: American Psychological Association.
Gatchel, R.J. (2004). Clinical Essentials of Pain Management. Washington, DC: APA Books.
Gatchel, R.J. & Turk, D.C. (1999). Psychosocial Factors in Pain: Critical Perspectives New York: Guilford Press.
Gatchel, R.J. and Weisberg, J.N. (2000). Personality Characteristics of Patients with Pain. Washington, DC: APA Books.
Turk, D.C. & Gatchel, R.J. (2002). Psychological Approaches to Pain Management: A Practitioner’s Handbook 2nd edition. New York: Guilford Press.
Turk, D.C. and Melzack, R. (1992). Handbook of Pain Assessment. New York, New York: Guilford Press.
Winterowd, C., Beck, A.T., Gruener, D. (2003). Cognitive Therapy with Chronic Pain Patients. New York: Springer Publication Company
REFERENCES
Medications and Opioid Use in Chronic Pain Patients
American Academy of Pain Medicine, American Pain Society, & the American Society of Addiction Medicine. (2001). Definitions related to the use of opioids for the treatment of pain: A consensus document. AAPM, APS and ASAM.
American Pain Foundation. (2001a). Pain Action Guide. Baltimore, MD: author. Available at the website, www.painfoundation.org or American Pain Foundation, 210 N. Charles Street, Suite 710, Baltimore, MD, 21201.
American Pain Foundation. (2001b). Pain Care Bill of Rights. Baltimore, MD: Author. Available at the website, www.painfoundation.org or American Pain Foundation, 210 N. Charles Street, Suite 710, Baltimore, MD, 21201, 888-615-PAIN (7246).
American Pain Society (1992). Principles of analgesic use in the treatment of acute pain and chronic cancer pain: A concise guide to medical practice (3rd ed.). Glenview, IL: Author. Available at the website, www.ampainsoc.org, or
American Pain Society, 4700 W. Lake Ave, Glenview, IL, 60025, 847-375-4715.
American Pain Society (2001). Promoting pain relief and preventing abuse of pain medications: A critical balancing act. A joint statement from 21 Health Organizations and the Drug Enforcement Administration. Available at the website, www.ampainsoc.org, or American Pain Society, 4700 W. Lake Ave, Glenview, IL, 60025, 847-375-4715.
Breckenridge, J. and Clark, D. (2003). Patient characteristics associated with Opioid versus nonsteroidal anti-inflammatory drug management of chronic low back pain. The Journal of Pain, 4, 344-350.
Chou et al. (2009). Opioid treatment guidelines: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. The Journal of Pain, 10, 113-130.
Christensen, D. and Kayser, V. (2000). The development of pain-related behavior and Opioid tolerance after neuropathy-induced and sham surgery. Pain, 88, 231-238.
Cleary, J., & Backonja, M. (1996). “Translating opioid tolerance research. APS Bulletin, March/April, 4-7
Doverty, M.J., White, J.M. et al. (2001). Hyperalgesic responses methadone maintenance patients. Pain, 90, 91-96.
Ersek, M., Cherrier, M.M. et al. (2004). The cognitive effects of opioids. Pain Management Nursing, 5, 75-93.
Fanciullo, G.J. et al. (2002). An observational study on the prevalence and pattern of Opioid use in 25,479 patients with spine and radicular pain. Spine, 27, 201-205.
Filling, R.B., Doleys, D.M. et al. (2003). Clinical characteristics of chronic back pain as a function of gender and oral Opioid use. Spine, 28, 143-150.
Harden, R.N. (2002). Chronic Opioid therapy: Another reappraisal. APS Bulletin, 12, 1-12.
Passik, S.D. and Kirsh, K.L. (2004). Opioid therapy in patients with a history of substance abuse. CNS Drugs, 18, 13-25.
Portenoy, R.K. (1994). Opioid therapy for chronic nonmalignant pain: Current status. In H.L. Fields & J.C. Liebeskind (Eds.). Progress in pain research and management, Vol. 1 (pp. 247-287). Seattle: IASP Press.
Portenoy, R.K. (1996). Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J. Pain Symptom Management, 203-217.
Porter, J., & Jick, H. (1980). Addiction is rare in patients treated with narcotics. New England Journal of Medicine, 302, 123.
Schofferman, J. (1999). Long-term Opioid analgesic therapy for severe refractory lumbar spine pain. Clin. J. Pain, 15, 136-140.
See, S. and Ginzburg, R. (2008a). Skeletal muscle relaxants. Pharmacotherapy, 28, 207-213.
See, S. and Ginzburg, R. (2008b). Choosing a skeletal muscle relaxant. American Family Physician, 78, 365-370.
Turk, D.C., Okifuji, A. (1997). What factors affect physicians’ decision to prescribe opioids for chronic noncancer pain patient? Clin J Pain, 13, 330-336.
White, J.M. (2004). Pleasure into pain: the consequences of long-term opioid use. Addictive Behavior, 29, 1311-1324.
Zenz, M., Strumf, M., & Tryba, M. (1992). Long-term opioid therapy in patients with chronic nonmalignant pain. Journal of Pain and Symptom Management, 7, 69-77.
Aggressive Conservative Treatment
Fordyce, W.E. (1988). Pain and suffering: A reappraisal. American Psychologist, 43, 276-283.
Gatchel, R.J. (1991). Early development of physical and mental deconditioning in painful spinal disorder. In T.G. Mayer, V. Mooney, & R.J.
Gatchel (Eds.), Contemporary conservative care for painful spinal disorders (pp. 278-289). Philadelphia: Lea & Febiger.
Gatchel, R.J. (1996). Psychological disorders and chronic pain: Cause and effect relationships. In R.J. Gatchel and D.C. Turk (Eds.), Psychological approaches to pain management: A practitioner’s handbook (pp. 33-52). New York: Guilford Press.
Gatchel, R.J. (2004). Clinical Essentials of Pain Management. Washington, DC: APA Books.
Gatchel, R.J., (Ed)., Andersson, G. , Deardorff, W.W. et al. (2001). A Compendium of outcome instruments for assessment & research of spinal disorders. Chicago: North American Spine Society.
Melzack, R. and Wall, P.D. (1965). Pain mechanisms: A new theory. Science, 150, 971-979.
Melzack, R. and Wall, P.D. (1982). The Challenge of Pain. New York: Basic Books.
Sinel, M.S. and Deardorff, W.W. (1999). Back Pain Remedies for Dummies. Chicago: IDG Worldwide Publications. (a health book in the “Dummies” series).
Sinel, M.S., Deardorff, W.W. & Goldstein, T.B. (1996). Win the Battle Against Back Pain: An Integrated Mind-Body Approach. New York: Bantam-Doubleday-Dell.
Sternbach, R.A. (1987). Mastering Pain. New York: Ballantine Books.
Review Articles-Spinal Cord Stimulation
Bala et al. (2006). Systematic review of the (cost-) effectiveness of spinal cord stimulation for people with chronic pain. Kleijnen Systematic Reviews: York, UK.
Beltrutti , D. et al. (2004). The psychological assessment of candidates for spinal cord stimulation for chronic pain management: Expert Panel Report. Pain Practice, 4, 204-221.
Health Technology Review. (2005). Spinal Cord Stimulation for Neuropathic Pain. Ministry of Health and Long-Term Care: Toronto, ON, Canada.
Mailis-Gagnon, A. et al (2004). Spinal cord stimulation for chronic pain. Cochrane Database of Systematic Review, Issue 3. Art. No.: CD003783. DOI: 10.1002/14651858.CD003783.pub2.
North, R. et al. (2007). Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain. Pain Medicine, 8, S200-S275.
Spinal Cord Stimulation Screening
Block, A., Gatchel, R.J., Deardorff, W.W. and Guyer, R. (2003). The Psychology of Spine Surgery. Washington, D.C.: American Psychological Association Press.
Deardorff, W.W. (2000). Pre-surgical psychological screenings for spine surgeries, stimulators and implantable pumps. Workers Compensation Enquirer, 17, 29-32.
Doleys, D.M. (2206). Psychological factors in spinal cord stimulation therapy: brief review and discussion. Neurosurgical Focus, 21, E1-6.
Doleys, D.M. (2002). Preparing patients for implantable technologies. In D.C. Turk and R.J. Gatchel (Eds.), Psychological approaches to pain management: A practitioner’s handbook (2nd Edition, pp. 334-348). New York: The Guilford Press.
Doleys, D.M. (2000). Psychological assessment for implantable therapies. Pain Digest, 10, 16-23.
Doleys, D.M. and Olson, K. (1997). Psychological assessment and intervention in implantable pain therapies. Minneapolis, MN: Medtronic.
Heckler, D.R. et al. (2007). Presurgical behavioral medicine evaluation (PBME) for implantable devices for pain management: A 1-year prospective study. Pain Practice, 7, 110-122.
Kemler, M.A., Barendse, G. A. et al (2000). Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N. England J. of Medicine, 343, 618-624.
Kemler, M.A., Furnee, CA. (2002). Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology, 59, 1203-1209.
Kumar, K., Toth, C. et al (1998). Epidural spinal cord stimulation for treatment of chronic pain-Some predictors of success. A 15-year experience. Surg Neurol, 50, 110-121.
Manchikanti, L. et al. (2003). Evidence-Based Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain. Pain Physician, 6, 3-81.
Mueller-Schwefe, G., Hassenbusch, S.J., Rieg, E. (1999). Cost-effectiveness of intrathecal therapy for pain. Neuromodulation, 2, 77-84.
Nelson, D.V., Kennington, M. (1996). Psychological selection criteria for implantable spinal cord stimulators. Pain Forum, 5, 93-103.
Nelson, D.V., Kennington, M. (1996). Psychological considerations in implantable technology. Pain Forum, 5, 121-126.
North, R.B. (1996). Psychological criteria are outcome measures as well as prognostic factors. Pain Forum, 5, 111-114.
North, R.B., Kidd, D.H. (1996). Prognostic value of psychological testing in patients undergoing spinal cord stimulation: a prospective study. Neurosurgery, 39, 301-311.
Turner, J.A., Loeser, J.D., Deyo, S.B., Sanders, S.B. (2004). Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain, 108, 137-147.
Williams, D.A. (1996). Psychological screening and treatment for implantables: A continuum of care. Pain orum, 5, 115-117.
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as hot packs, massage, and ultrasound are generally not indicated as part of the program since this tends to place the patient back in the sick-role. Use of ice or self-administered hot packs to help relieve symptomatic pain in conjunction with aggressive exercise may be appropriate. 
pain coverage as determined by the dermatomes associated with the spinal nerves. A dermatome is an area of skin associated with a pair of dorsal roots from the spine. The lead will often cover more than one vertebral level of the spine to cover the painful area. The adequacy of paresthesia coverage of the painful dermatomes determines the success of the spinal cord stimulation treatment. Dermatomes are 
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