Recommended for selected patients, due to risks of weaning. Early research indicates that switching from rapid-onset, short-acting benzodiazepines to slow-onset, long-acting formulations is an option. In some cases this will actually allow for ultimate discontinuation of this class of drugs. Clonazepam is the suggested drug to switch to. It has a slow onset of action, half-life of 18-50 hours, high potency and lack of active metabolites. (Liebrenz, 2010) (Maremmani, 2013) See also Weaning, benzodiazepines (specific guidelines).
See Intravenous regional sympathetic blocks (for RSD/CRPS).
Not recommended as a stand-alone treatment, but recommended as an option in a cognitive behavioral therapy (CBT) program to facilitate exercise therapy and return to activity. There is fairly good evidence that biofeedback helps in back muscle strengthening, but evidence is insufficient to demonstrate the effectiveness of biofeedback for treatment of chronic pain. Biofeedback may be approved if it facilitates entry into a CBT treatment program, where there is strong evidence of success. As with yoga, since outcomes from biofeedback are very dependent on the highly motivated self-disciplined patient, we recommend approval only when requested by such a patient, but not adoption for use by any patient. EMG biofeedback may be used as part of a behavioral treatment program, with the assumption that the ability to reduce muscle tension will be improved through feedback of data regarding degree of muscle tension to the subject. The potential benefits of biofeedback include pain reduction because the patient may gain a feeling that he is in control and pain is a manageable symptom. Biofeedback techniques are likely to use surface EMG feedback so the patient learns to control the degree of muscle contraction. The available evidence does not clearly show whether biofeedback's effects exceed nonspecific placebo effects. It is also unclear whether biofeedback adds to the effectiveness of relaxation training alone. The application of biofeedback to patients with CRPS is not well researched. However, based on CRPS symptomology, temperature or skin conductance feedback modalities may be of particular interest. (Keefe, 1981) (Nouwen, 1983) (Bush, 1985) (Croce, 1986) (Stuckey, 1986) (Asfour, 1990) (Altmaier, 1992) (Flor, 1993) (Newton-John, 1995) (Spence, 1995) (Vlaeyen, 1995) (NIH-JAMA, 1996) (van Tulder, 1997) (Buckelew, 1998) (Hasenbring, 1999) (Dursun, 2001) (van Santen, 2002) (Astin, 2002) (State, 2002) (BlueCross BlueShield, 2004) This recent report on 11 chronic whiplash patients found that, after 4 weeks of myofeedback training, there was a trend for decreased disability in 36% of the patients. The authors recommended a randomized-controlled trial to further explore the effects of myofeedback training. (Voerman, 2006) Functional MRI has been proposed as a method to control brain activation of pain. See Functional imaging of brain responses to pain.
ODG biofeedback therapy guidelines:
Screen for patients with risk factors for delayed recovery, as well as motivation to comply with a treatment regimen that requires self-discipline.
Initial therapy for these “at risk” patients should be physical therapyexercise instruction, using a cognitive motivational approach to PT.
Possibly consider biofeedback referral in conjunction with CBT after 4 weeks:
- Initial trial of 3-4 psychotherapy visits over 2 weeks
- With evidence of objective functional improvement, total of up to 6-10 visits over 5-6 weeks (individual sessions)
- Patients may continue biofeedback exercises at home
Biopsychosocial model of chronic pain
See “Introduction to the MTUS Chronic Pain Guideline” for a definition and detailed description. Chronic pain programs (multidisciplinary pain programs or functional restoration programs), are recommended for patients with conditions that put them at risk of delayed recovery where there is access to programs with proven successful outcomes.
Recommend treatment of bone resorption with bisphosphonate-type compounds as an option for patients with CRPS Type I. Not recommended for other chronic pain conditions. Significant improvement has been found in limited studies of intravenous clodronate and intravenous alendronate. Alendronate (Fosamax®) given in oral doses of 40 mg a day (over an 8-week period) produced improvements in pain, pressure tolerance and joint moblity. The effects may potentially involve avenues other than inhibition of bone resorption. (Manicourt, 2004) However, use has been associated with complications including osteonecrosis of the jaw and possible increased risk of long bone fractures including the femur. (Mehrotra, 2006) See also CRPS, medications. Bisphosphonates are a class of drugs that inhibit osteoclast action and the resorption of bone. Alendronate (Fosamax®) is in this class.
Bone scan (for CRPS)
See CRPS, diagnostic tests.
Boswellia Serrata Resin (Frankincense)
Recommended as an option for knee osteoarthritis, but more studies are needed to validate early results. A statistically significant improvement in arthritis of the knee was shown after 8 weeks of treatment with 333 mg B. serrata extract taken three times a day. The treatment improved function, but radiographically there was no change in the affected joints. (Maroon, 2006) This RCT concluded that 5-Loxin (a proprietary version of Boswellia serrata extract enriched with 30% AKBA) reduces pain and improves physical functioning significantly in patients with osteoarthritis of the knee, and it is safe for human consumption. (Sengupta, 2008)
See Botulinum toxin.
Botulinum toxin (Botox®; Myobloc®)
Not generally recommended for most chronic pain conditions. See more details below, and refer also to specific DWC MTUS body chapters.
No recommendation: myofascial pain syndromes(MPS):
Recent reviews find inconclusive evidence to support the use of botulinum toxin in the treatment of MPS. (Soares Cochrane, 2014) Contradictory study results regarding the efficacy of Botulinum toxin A in MPS associated with neck and back pain do not allow this treatment to be recommended or rejected. (Climent, 2013)
Under study: migraine headache. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month. (FDA, 2010) A systematic review of RCTs concluded that Botulinum toxin A compared with placebo was associated with a small to modest benefit for chronic daily headaches and chronic migraines but was not associated with fewer episodic migraine or chronic tension-type headaches per month. (Jackson 2012) The FDA approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. It is recommended as a second-line therapy (since other acute therapies should have been attempted).
Indicated as an option for treatment of chronic pain (consensus based) in selected patients (not first-line for all patients). Suggested populations: (1) Patients with a hyperalgesic component to pain; (2) Patients with centrally mediated pain; (3) Patients with neuropathic pain; (4) Patients at high-risk of non-adherence with standard opioid maintenance; (5) For analgesia in patients who have previously been detoxified from other high-dose opioids. Use for pain with formulations other than Butrans is off-label. Due to complexity of induction and treatment the drug should be reserved for use by clinicians with experience.
Drug description: Buprenorphine is a schedule-III controlled substance. Its mechanism of action is complex, involving four different opioid receptors at central and peripheral sites. It is primarily classified as a partial mu-agonist and kappa antagonist. It blocks effects of subsequently administered opioid agonists.
There is the potential for buprenorphine to precipitate withdrawal in opioid-experienced patients.
Buprenorphine hydrochloride sublingual tablets (Subutex® [innovator brand is off market]; generics available): 2 mg and 8 mg.
Buprenorphine hydrochloride and naloxone hydrochloride sublingual film (Suboxone®; no generics): Available as a film in doses of buprenorphine/ naloxone of 2mg/0.5mg, 4mg/1 mg, 8mg/2 mg and 12mg/3 mg. Tablet formulations are available as 2mg/0.5mg and 8mg/2mgs. Discontinuation of branded Suboxone sublingual tablets is to occur on 3/18/13, being replaced by the sublingual film described above.
Buprenorphine transdermal system (Butrans®; no generics): FDA-approved for moderate to severe chronic pain. Available as transdermal patches at 5mcg/hr, 10mcg/hr and 20mcg/hr.
See also Buprenorphine for treatment of opioid dependence.
Buprenorphine for opioid dependence
The use of buprenorphine maintenance therapy was introduced in 2002. This drug can be prescribed in a physician office setting for this indication by certified physicians. Original studies investigate the use of buprenorphine for treatment of heroin addiction and research is still ongoing for use in populations with prescription drug abuse, or with comorbid dependency and chronic pain.
Drug characteristics in terms of dependence and addiction treatment: The drug is a semi-synthetic mu opioid partial agonist and a kappa receptor antagonist. The medication as used for this indication is available in sublingual tablet or film formulations. Current literature indicates many of the drug’s effects plateau at 16 mg, although doses of 32 mg are used clinically. Most patients stabilize at doses between 16 and 24 mg given in a once daily dose. The intensity of the rewarding effect is milder and plateaus at higher doses, and these characteristics are thought to limit abuse potential. (Alford, 2011) (Clark, 2011) (Weiss, 2011) (Bart, 2012) (Ducharme, 2012) (Mark, 2012) (Colson, 2012) Zubsolv (buprenorphine and naloxone), a recently FDA-approved medication for maintenance treatment of opioid dependence, is a once-daily sublingual tablet that offers higher bioavailability that allows patients to use lower strength and reduce the amount of available drug for potential misuse and diversion. (FDA, 2013) See also Buprenorphine for treatment of chronic pain; & Weaning, opioids (specific guidelines).
Recommended as an option after other agents. Bupropion has shown some efficacy in neuropathic pain. Furthermore, bupropion is generally a third-line medication for diabetic neuropathy and may be considered when patients have not had a response to a tricyclic or SNRI. See specific Bupropion listing in section on Antidepressants for chronic pain for more information and references.
Recommended as a treatment option for patients with CRPS Type I with a contraindication for treatment of bone resorption with a bisphosphonate. Not recommended for other chronic pain conditions. Signifcant improvement has been found in limited studies of intravenous clodronate and intravenous alendronate. Alendronate (Fosamax®) given in oral doses of 40 mg a day (over an 8 week period) produced improvements in pain, pressure tolerance and joint moblity. (Manicourt, 2004) Mixed results have been found with intranasal calcitonin (Miacalcin®). (Sahin, 2005) (Appelboom, 2002) (Rowbathan, 2006) (Sharma, 2006) See also CRPS, medications. Calcitonin is a hormone known to participate in calcium and phosphorus metabolism.
Not recommended for pain. Under study for epilepsy. A growing number of states (23 at the time of publication of this guideline) (NCSL, 2013) have approved the use of medical marijuana for the treatment of chronic pain, but there are no quality studies supporting cannabinoid use, and there are serious risks. Restricted legal access to Schedule I drugs, such as marijuana, tends to hamper research in this area. It is also very hard to do controlled studies with a drug that is psychoactive because it is hard to blind these effects. At this time it is difficult to justify advising patients to smoke street-grade marijuana, presuming that they will experience benefit, when they may also be harmed. (Mackie, 2007) (Moskowitz, 2007) One of the first dose-response studies of cannabis in humans has found that mid-range doses provided some pain relief, but high doses appeared to exacerbate pain. (Wallace, 2007) Cannabis use is associated with modest declines in cognitive performance, particularly learning and recall, especially at higher doses. The finding necessitates caution in the prescribing of medical marijuana for pain, especially in instances in which learning and memory are integral to a patient's work and lifestyle. (Wilsey, 2008) Cannabinoids as analgesic agents can have an undesirable CNS impact, and, in many cases, dose optimization may not be realizable before onset of excessive side effects. (McCarberg, 2007) This study concluded that nabilone, a synthetic cannabinoid approved for treatment of severe nausea and vomiting associated with cancer chemotherapy, may be a useful addition to pain management and should be further evaluated in randomized controlled trials. (Berlach, 2006) See also Nabilone (Cesamet®). The results of this preliminary study suggest that dronabinol, a synthetic THC, resulted in additional analgesia among patients taking opioids for chronic noncancer pain. (Narang, 2008) Adding a cannabinoid to opioid therapy may lead to greater pain relief at lower opioid doses, according to a new study, but more study is needed. (Abrams, 2011)
Recent research: Cannabis users who start using the drug as adolescents show an irreparable decline in IQ, with more persistent use linked to a greater decline, according to a New Zealand prospective study with over 1,000 patients. Adolescents are particularly vulnerable to developing cognitive impairment from cannabis and the drug, far from being harmless, as many teens and even adults believe, can have severe neurotoxic effects on the brain. Between the ages of 8 and 38 years, individuals who began using cannabis in adolescence and continued to use it for years thereafter lost an average of 8 IQ points, versus rising slightly in nonusers. Cessation of cannabis did not restore IQ among teen-onset cannabis users. Cannabis in New Zealand has a THC content of approximately 9%. (Meier, 2013) The American Society of Addiction Medicine (ASAM) has taken a position against medical marijuana, saying physicians should not recommend that patients use marijuana for medical purposes, because it is a dangerous, addictive drug and is not approved by the FDA. Cannabis is unstable and unpredictable and the drug should be subject to the same standards that apply to other medications. For every disease and disorder for which marijuana has been recommended, there is a better, FDA-approved medication. (Gitlow, 2013) An RCT of smoked marijuana and oral dronabinol (tetrahydrocannabinol; THC) showed that both produce an analgesic effect, but this effect lasts longer with dronabinol, and it is less subject to abuse. Reported advantages to smoked marijuana are its faster onset and the relative ease with which doses can be managed, but it is not always safe or feasible to smoke marijuana. In addition to the cardiopulmonary risks this carries, smoking anything is not acceptable, such as on an airplane or at work. On the other hand, dronabinol is not approved for pain, only for chemotherapy-induced nausea and AIDS-related weight loss. And, the recommended doses (2.5 mg to 5 mg) are much lower than those used in this study (10 mg to 20 mg) that seemed to have an effect on pain. (Cooper, 2013) The 2 main chemical ingredients in marijuana, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), can have very different effects on behavior and in the brain, this research shows. Even a single modest dose of THC, the main ingredient in marijuana that is responsible for the high, can induce psychotic symptoms, whereas CBD can be useful as a treatment for psychosis. Regular marijuana use in vulnerable individuals is associated with increased risk of developing psychotic disorders such as schizophrenia, in which patients lose contact with reality. CBD, on the other hand, had the opposite effect, increasing the response of the left caudate, an area of the brain weakened by THC. (Bhattacharyya, 2012) Long-term marijuana use has been linked to structural brain changes similar to those observed in schizophrenia patients, and they correlate with poorer working memory. Teens who smoked marijuana daily for about 3 years performed poorly on tests of working memory and had abnormal changes in brain structures akin to those seen in patients with schizophrenia, linking long-term use of marijuana to brain abnormalities that appear to last for at least a few years after people stop using it. (Smith, 2013)
Epilepsy: Cannabinoids have therapeutic potential in epilepsy, but their efficacy and safety remain to be proven. There are no controlled trials demonstrating that marijuana is safe or effective for the treatment of epilepsy. On the other hand, there is evidence that marijuana may be harmful, particularly in the developing brain after regular use. Synthetic cannabinoids appear even more toxic. For patients who have exhausted conventional therapies, medical marijuana, with anecdotal evidence of seizure control, could be considered as an alternative therapy. Such use should be carefully monitored by a physician. (Robson, 2014)
Capsaicin, topical (chili pepper/ cayenne pepper)
Recommended only as an option in patients who have not responded or are intolerant to other treatments.
Formulations: Capsaicin is generally available as a 0.025% formulation (as a treatment for osteoarthritis) and a 0.075% formulation (primarily studied for post-herpetic neuralgia, diabetic neuropathy and post-mastectomy pain). There have been no studies of a 0.0375% formulation of capsaicin and there is no current indication that this increase over a 0.025% formulation would provide any further efficacy.
Indications: There are positive randomized studies with capsaicin cream in patients with osteoarthritis, fibromyalgia, and chronic non-specific back pain, but it should be considered experimental in very high doses. Although topical capsaicin has moderate to poor efficacy, it may be particularly useful (alone or in conjunction with other modalities) in patients whose pain has not been controlled successfully with conventional therapy. The number needed to treat in musculoskeletal conditions was 8.1. The number needed to treat for neuropathic conditions was 5.7. (Robbins, 2000) (Keitel, 2001) (Mason-BMJ, 2004) The results from this RCT support the beneficial effects of 0.025% capsaicin cream as a first-line therapy for OA pain. (Altman, 1994)
Mechanism of action: Capsaicin, which is derived from chili peppers, causes vasodilation, itching, and burning when applied to the skin. These actions are attributed to binding with nociceptors, which causes a period of enhanced sensitivity followed by a refractory period of reduced sensitivity. Topical capsaicin is superior to placebo in relieving chronic neuropathic and musculoskeletal pain. Capsaicin produces highly selective regional anesthesia by causing degeneration of capsaicin-sensitive nociceptive nerve endings, which can produce significant and long lasting increases in nociceptive thresholds. (Maroon, 2006)
Adverse reactions: Local adverse reactions were common (one out of three patients) but seldom serious (burning, stinging, erythema). Coughing has also been reported. Topical OTC pain relievers that contain menthol, methyl salicylate, or capsaicin, may in rare instances cause serious burns, a new alert from the FDA warns. (FDA, 2012) See also CRPS, medications; Diabetic neuropathy; & Topical analgesics. See also Herbal medicines.
See Anti-epilepsy drugs (AEDs) for general guidelines, as well as specific Carbamazepine listing.
Not recommended. This medication is FDA-approved for symptomatic relief of discomfort associated with acute pain in musculoskeletal conditions as an adjunct to rest and physical therapy. (AHFS, 2008) This medication is not indicated for long-term use. Carisoprodol is a commonly prescribed, centrally acting skeletal muscle relaxant whose primary active metabolite is meprobamate (a Schedule-IV controlled substance). As of January 2012, carisoprodol is scheduled by the DEA as a Schedule IV medication. (DEA, 2012) It has been suggested that the main effect is due to generalized sedation and treatment of anxiety.
Beers criteria: The AGS updated Beers criteria for inappropriate medication use includes carisoprodol. This is a list of potentially inappropriate medications for older adults. (AGS, 2012)
Abuse:Abuse has been noted for sedative and relaxant effects. In regular abusers the main concern is the accumulation of meprobamate. Carisoprodol abuse has also been noted in order to augment or alter effects of other drugs. This includes the following: (1) increasing sedation of benzodiazepines or alcohol; (2) use to prevent side effects of cocaine; (3) use with tramadol to produce relaxation and euphoria; (4) as a combination with hydrocodone, an effect that some abusers claim is similar to heroin (referred to as a “Las Vegas Cocktail”); & (5) as a combination with codeine (referred to as “Soma Coma”). (Reeves, 1999) (Reeves, 2001) (Reeves, 2008) (Schears, 2004) (Owens, 2007) (Reeves, 2012) There was a 300% increase in numbers of emergency room episodes related to carisoprodol from 1994 to 2005. (DHSS, 2005) Hospital emergency department visits involving the misuse of carisoprodol have doubled over five years, study shows. (SAMHSA, 2011)
Intoxication signs:Intoxication appears to include subdued consciousness, decreased cognitive function, and abnormalities of the eyes, vestibular function, appearance, gait and motor function. Intoxication includes the effects of both carisoprodol and meprobamate, both of which act on different neurotransmitters. (Bramness, 2007) (Bramness, 2004)
Withdrawal:A withdrawal syndrome has been documented that consists of insomnia, vomiting, tremors, muscle twitching, anxiety, and ataxia when abrupt discontinuation of large doses occurs. This is similar to withdrawal from meprobamate. (Reeves, 2010) (Reeves, 2007) (Reeves, 2004)
Weaning: There is little research in terms of weaning of high dose carisoprodol and there is no standard treatment regimen for patients with known dependence. Most treatment includes treatment for symptomatic complaints of withdrawal. Another option is to switch to phenobarbital to prevent withdrawal with subsequent tapering. A maximum dose of phenobarbital is 500 mg/day and the taper is 30 mg/day with a slower taper in an outpatient setting. Tapering should be individualized for each patient. (Boothby, 2003) For more information and references, see Muscle relaxants. See also Weaning, carisoprodol (Soma®).
See Clonidine, intrathecal.
Recommend determination of causation typically involving mechanism of injury, temporal relationship, and dose effect. See specific body-part chapters in the DWC MTUS.
Celebrex® is the brandname for celecoxib, and it is produced by Pfizer. Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) that is a COX-2 selective inhibitor, a drug that directly targets COX-2, an enzyme responsible for inflammation and pain. See Anti-inflammatory medications. See NSAIDs (non-steroidal anti-inflammatory drugs) for specific patient decision-making criteria. Unlike other NSAIDs, celecoxib does not appear to interfere with the antiplatelet activity of aspirin and is bleeding neutral when patients are being considered for surgical intervention or interventional pain procedures.
See Celebrex® above. See also NSAIDs (non-steroidal anti-inflammatory drugs); NSAIDs, GI symptoms & cardiovascular risk; NSAIDs, hypertension and renal function; & NSAIDs, specific drug list & adverse effects for general guidelines, as well as specific Celecoxib (Celebrex®) listing for more information and references. A large systematic review of available evidence on NSAIDs confirms that naproxen and low-dose ibuprofen are least likely to increase cardiovascular risk. Celecoxib (Celebrex), on the whole, had a slightly increased risk of cardiovascular events at low and high doses, although there were few studies testing doses >200 mg/day. Celecoxib, especially at doses >400 mg/day, should be avoided in patients at high risk of cardiovascular disease. (McGettigan, 2011)
Recommended as indicated below. Cellulitis is a common, potentially serious bacterial skin infection, entering the skin usually via a cut or abrasion. The lower legs are most commonly affected, but cellulitis can occur anywhere on the body. Staphylococcus and streptococcus bacteria are the most common causes of cellulitis. Oral antibiotics are effective in over 90% of patients, but almost all abscesses require drainage for resolution, regardless of the microbiology of the infection. A peripherally inserted central catheter (PICC line), a form of intravenous access that can be used for a prolonged period of time for extended antibiotic therapy, may be required. Urgent consultation with a surgeon should be sought in cases of crepitus, circumferential cellulitis, necrotic-appearing skin, rapidly evolving cellulitis, pain disproportional to physical examination findings, severe pain on passive movement, or other clinical indications of necrotizing fasciitis. (Stevens, 2005) (Liu, 2011)
Under study for lymphedema, but not recommended for other conditions, including chronic pain, since there is no evidence of its effectiveness.
See Manual therapy & manipulation.
Not recommended. See Benzodiazepines.
See Vitamin D.
See Glucosamine (and Chondroitin Sulfate).
Chronic pain programs /Multidisciplinary Programs
(also see Functional restoration programs [FRPs])
Recommended where there is access to programs with proven successful outcomes (i.e., decreased pain and medication use, improved function and return to work, decreased utilization of the health care system), for patients with conditions that have resulted in “Delayed recovery.” Also see “Introduction to the MTUS Chronic Pain Guideline.” There should be evidence that a complete diagnostic assessment has been made, with a detailed treatment plan of how to address physiologic, psychological and sociologic components that are considered components of the patient’s pain. Patients should show evidence of motivation to improve and return to work, and meet the patient selection criteria outlined below. While these programs are recommended (see criteria below), the research remains ongoing as to (1) what is considered the “gold-standard” content for treatment; (2) the group of patients that benefit most from this treatment; (3) the ideal timing of when to initiate treatment; (4) the intensity necessary for effective treatment; and (5) cost-effectiveness. It has been suggested that interdisciplinary/multidisciplinary care models for treatment of chronic pain may be the most effective way to treat this condition. (Flor, 1992) (Gallagher, 1999) (Guzman, 2001) (Gross, 2005) (Sullivan, 2005) (Dysvik, 2005) (Airaksinen, 2006) (Schonstein, 2003) (Sanders, 2005) (Patrick, 2004) (Buchner, 2006) These treatment modalities are based on the biopsychosocial model, one that views pain and disability in terms of the interaction between physiological, psychological and social factors. (Gatchel, 2005) See Biopsychosocial model of chronic pain.
Types of programs: There is no one universal definition of what comprises interdisciplinary/multidisciplinary treatment. These pain rehabilitation programs (as described below) combine multiple treatments, and at the least, include psychological care along with physical and/or occupational therapy (including an active exercise component as opposed to passive modalities). The most commonly referenced programs have been defined in the following general ways (Stanos, 2006):
(1) Multidisciplinary programs: Involves one or two specialists directing the services of a number of team members, with these specialists often having independent goals. These programs can be further subdivided into four levels of pain programs:
(a) Multidisciplinary pain centers (generally associated with academic centers and include research as part of their focus)
(b) Multidisciplinary pain clinics
(c) Pain clinics
(d) Modality-oriented clinics
(2) Interdisciplinary pain programs: Involves a team approach that is outcome focused and coordinated and offers goal-oriented interdisciplinary services. Communication on a minimum of a weekly basis is emphasized. The most intensive of these programs is referred to as a Functional Restoration Program, with a major emphasis on maximizing function versus minimizing pain. See Functional restoration programs.
Types of treatment:Components suggested for interdisciplinary care include the following services delivered in an integrated fashion: (a) physical treatment; (b) medical care and supervision; (c) psychological and behavioral care; (d) psychosocial care; (e) vocational rehabilitation and training; and (f) education.
Outcomes measured: Studies have generally evaluated variables such as pain relief, function and return to work. More recent research has begun to investigate the role of comorbid psychiatric and substance abuse problems in relation to treatment with pain programs. Recent literature has begun to suggest that an outcome of chronic pain programs may be to “demedicalize” treatment of a patient, and encourage them to take a more active role in their recovery. These studies use outcomes such as use of the medical care system post-treatment. The role of the increasing use of opioids and other medications (using data collected over the past decade) on outcomes of functional restoration is in the early stages, and it is not clear how changes in medication management have affected outcomes, if at all.
See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids. Also see specific body-part chapters in the DWC MTUS.
Multidisciplinary back training: (involvement of psychologists, physiotherapists, occupational therapists, and/or medical specialists). The training program is partly based on physical training and partly on behavioral cognitive training. Physical training is performed according to the “graded activity” principle. The main goal is to restore daily function. A recent review of randomized controlled studies of at least a year’s duration found that this treatment modality produced a positive effect on work participation and possibly on quality of life. There was no long-term effect on experienced pain or functional status (this result may be secondary to the instrument used for outcome measure). Intensity of training had no substantial influence on the effectiveness of the treatment. (van Geen, 2007) (Bendix, 1997) (Bendix, 1998) (Bendix2, 1998) (Bendix, 2000) (Frost, 1998) (Harkapaa, 1990) (Skouen, 2002) (Mellin, 1990) (Haldorsen, 2002)
Intensive multidisciplinary rehabilitation of chronic low back pain: The most recent Cochrane study was withdrawn from the Cochrane (3/06) as the last literature search was performed in 1998. Studies selected included a physical dimension treatment and at least one other treatment.
Role of opioid use: See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids.
Role of comorbid psychiatric illness: Comorbid conditions, including psychopathology, should be recognized as they can affect the course of chronic pain treatment. In a recent analysis, patients with panic disorder, antisocial personality disorder and dependent personality disorder were > 2 times more likely to not complete an interdisciplinary program. Personality disorders in particular appear to hamper the ability to successfully complete treatment. Patients diagnosed with post-traumatic stress disorder were 4.2 times more likely to have additional surgeries to the original site of injury. (Dersh, 2007) The prevalence of depression and anxiety in patients with chronic pain is similar. Cohort studies indicate that the added morbidity of depression and anxiety with chronic pain is more strongly associated with severe pain and greater disability. (Poleshuck, 2009) (Bair, 2008)
Predictors of success and failure:As noted, one of the criticisms of interdisciplinary/multidisciplinary rehabilitation programs is the lack of an appropriate screening tool to help to determine who will most benefit from this treatment. Retrospective research has examined decreased rates of completion of functional restoration programs, and there is ongoing research to evaluate screening tools prior to entry. (Gatchel, 2006) There is need for research in terms of necessity and/or effectiveness of counseling for patients considered to be “at-risk” for post-discharge problems. (Proctor, 2004) The following variables have been found to be negative predictors of efficacy of treatment with the programs as well as negative predictors of completion of the programs: (1) a negative relationship with the employer/supervisor; (2) poor work adjustment and satisfaction; (3) a negative outlook about future employment; (4) high levels of psychosocial distress (higher pretreatment levels of depression, pain and disability); (5) involvement in financial disability disputes; (6) greater rates of smoking; (7) increased duration of pre-referral disability time; (8) higher prevalence of opioid use; and (9) elevated pre-treatment levels of pain. (Linton, 2001) (Bendix, 1998) (McGeary, 2006)(McGeary, 2004) (Gatchel2, 2005) (Dersh, 2007)
Role of duration of disability: There is little research as to the success of return to work with functional restoration programs in long-term disabled patients (> 24 months).
Studies supporting programs for patients with long-term disability: Long-term disabled patients (at least 18 months) vs. short-term disabled (4 to 8 months) were evaluated using Pride data (1990-1993). No control was given for patients that did not undergo a program. During the time studied program dropouts averaged 8% to 12%. (It does appear that at the time of this study, participants in the program were detoxified from opioids prior to beginning.) The long-term disabled group was more likely to have undergone spinal surgery, with this likelihood increasing with time. Return to work was statistically different between the short-term disabled (93%) and the long-term disabled-18 months (80%). The long-term disabled-24 months group had a 75% return to work. Long-term disabled-18 month patients were statistically more likely to visit new health providers than short-term disabled patients (34% and 25% respectively). Work retention at one year in groups up to 24 months duration of disability was 80%. This dropped to 66% in the group that had been disabled for > 24 months. The percentage of recurrent lost time injury claims increased from around 1% in the groups disabled for < 35 months to 8.3% in the groups disabled for > 36 months. A main criterion for success appeared to be the decision of the patient to actively participate in the program rehabilitation goals. (Jordan, 1998)
Studies suggesting limited results in patients with long-term disability: While early studies have suggested that time out-of-work is a predictor of success for occupational outcomes, these studies have flaws when an attempt is made to apply them to chronic pain programs. (Gallagher, 1989) (Beals, 1972) (Krause, 1994) Washington State studied the role of duration of work injury on outcome using a statistical model that allowed for a comparison of patients that participated in a multidisciplinary pain program (using data from 1991-1993) vs. those that were evaluated and not treated. This was not an actual study of time of disability, but of duration of injury (mean years from injury to evaluation of 2.6 years for the treated group and 4.0 years for the evaluated only group). The original statistical analysis allowed for a patient to be included in a “treated group” for those individuals that both completed and did not complete the program. Data was collected from 10 sites. Each of the centers was CARF approved and included Pysch/behavioral treatment, vocation counseling and physical therapy. A sub-study evaluated a comparison of patients that were treatment completers vs. those that did not participate (78.6%, N-=963). No information was given in terms of surgical procedures or medications. The primary outcome was time loss status of subjects 2 years after they had undergone the index pain center evaluation. In the 2001 study, if chronicity of duration of injury was controlled for, there was no significant benefit produced in terms of patients that were receiving time-loss benefits at 2-years post treatment between the two groups. Approximately 60% of both groups were not receiving benefits at the two-year period. As noted, the “treated patient” was only guaranteed to have started a program. A repeat analysis of only the patients who completed the study did not significantly change the results of the study. In a 2004 survey follow-up no significant difference was found between treated and untreated groups, although the treated group had better response. The survey response was 50%, and the treatment responders were more likely to be disabled at the time of the survey. The authors suggest that the results indicated early intervention was a key to response of the programs, and that modest goals (improvement, not cure) be introduced. (Robinson, 2004) (Robinson, 2001) [The authors also concluded that there was no evidence that pain center treatment affects either disability status or clinical status of injured workers.]
Timing of use: Intervention as early as 3 to 6 months post-injury may be recommended depending on identification of patients that may benefit from a multidisciplinary approach (from programs with documented positive outcomes). See Chronic pain programs, early intervention.
Role of post-treatment care (as an outcome): Three variables are usually examined; (1) New surgery at the involved anatomic site or area; (2) Percentage of patients seeking care from a new provider; (3) Number of visits to the new provider over and above visits with the health-care professional overseeing treatment. It is suggested that a “new provider” is more likely to reorder diagnostic tests, provide invasive procedures, and start long-term analgesics. In a study to determine the relationship between post-treatment healthcare-seeking behaviors and poorer outcomes (using prospectively analyzed PRIDE data on patients with work-related musculoskeletal injuries), patients were compared that accessed healthcare with a new provider following functional restoration program completion (approximately 25%) to those that did not. The former group was significantly more likely to have an attorney involved with their case (22.7% vs. 17.1%, respectively), and to have had pre-rehabilitation surgery (20.7% vs. 12.1%, respectively). Return to work was higher in the group that did not access a new provider (90% vs. 77.6% in the group that did access). The group that did not access new providers also was more likely to be working at one year (88% vs. 62.2% in the group that accessed new providers). It should be noted that 18% of the patients that entered the program dropped out or were asked to leave. The authors suggested monitoring of additional access of healthcare over and above that suggested at the end of the program, with intervention if needed. (Proctor, 2004) The latest AHRQ Comparative Effectiveness Research supports the ODG recommendations. (AHRQ, 2011)
See also Chronic pain programs, intensity; Chronic pain programs, opioids; Functional restoration programs; Chronic pain programs, early intervention; Progressive goal attainment program (PGAP™).
Criteria for the general use of multidisciplinary pain management programs:
Outpatient pain rehabilitation programs may be considered medically necessary in the following circumstances:
(1) The patient has a chronic pain syndrome, with evidence of loss of function that persists beyond three months and has evidence of three or more of the following: (a) Excessive dependence on health-care providers, spouse, or family; (b) Secondary physical deconditioning due to disuse and/or fear-avoidance of physical activity due to pain; (c) Withdrawal from social activities or normal contact with others, including work, recreation, or other social contacts; (d) Failure to restore preinjury function after a period of disability such that the physical capacity is insufficient to pursue work, family, or recreational needs; (e) Development of psychosocial sequelae that limits function or recovery after the initial incident, including anxiety, fear-avoidance, depression, sleep disorders, or nonorganic illness behaviors (with a reasonable probability to respond to treatment intervention); (f) The diagnosis is not primarily a personality disorder or psychological condition without a physical component; (g) There is evidence of continued use of prescription pain medications (particularly those that may result in tolerance, dependence or abuse) without evidence of improvement in pain or function.
(2) Previous methods of treating chronic pain have been unsuccessful and there is an absence of other options likely to result in significant clinical improvement.
(3) An adequate and thorough multidisciplinary evaluation has been made. This should include pertinent validated diagnostic testing that addresses the following: (a) A physical exam that rules out conditions that require treatment prior to initiating the program. All diagnostic procedures necessary to rule out treatable pathology, including imaging studies and invasive injections (used for diagnosis), should be completed prior to considering a patient a candidate for a program. The exception is diagnostic procedures that were repeatedly requested and not authorized. Although the primary emphasis is on the work-related injury, underlying non-work related pathology that contributes to pain and decreased function may need to be addressed and treated by a primary care physician prior to or coincident to starting treatment; (b) Evidence of a screening evaluation should be provided when addiction is present or strongly suspected; (c) Psychological testing using a validated instrument to identify pertinent areas that need to be addressed in the program (including but not limited to mood disorder, sleep disorder, relationship dysfunction, distorted beliefs about pain and disability, coping skills and/or locus of control regarding pain and medical care) or diagnoses that would better be addressed using other treatment should be performed; (d) An evaluation of social and vocational issues that require assessment.
(4) If a goal of treatment is to prevent or avoid controversial or optional surgery, a trial of 10 visits (80 hours) may be implemented to assess whether surgery may be avoided.
(5) If a primary reason for treatment in the program is addressing possible substance use issues, an evaluation with an addiction clinician may be indicated upon entering the program to establish the most appropriate treatment approach (pain program vs. substance dependence program). This must address evaluation of drug abuse or diversion (and prescribing drugs in a non-therapeutic manner). In this particular case, once drug abuse or diversion issues are addressed, a 10-day trial may help to establish a diagnosis, and determine if the patient is not better suited for treatment in a substance dependence program. Addiction consultation can be incorporated into a pain program. If there is indication that substance dependence may be a problem, there should be evidence that the program has the capability to address this type of pathology prior to approval.
(6) Once the evaluation is completed, a treatment plan should be presented with specifics for treatment of identified problems, and outcomes that will be followed.
(7) There should be documentation that the patient has motivation to change, and is willing to change their medication regimen (including decreasing or actually weaning substances known for dependence). There should also be some documentation that the patient is aware that successful treatment may change compensation and/or other secondary gains. In questionable cases, an opportunity for a brief treatment trial may improve assessment of patient motivation and/or willingness to decrease habituating medications.
(8) Negative predictors of success (as outlined above) should be identified, and if present, the pre-program goals should indicate how these will be addressed.
(9) If a program is planned for a patient that has been continuously disabled for greater than 24 months, the outcomes for the necessity of use should be clearly identified, as there is conflicting evidence that chronic pain programs provide return-to-work beyond this period. These other desirable types of outcomes include decreasing post-treatment care including medications, injections and surgery. This cautionary statement should not preclude patients off work for over two years from being admitted to a multidisciplinary pain management program with demonstrated positive outcomes in this population.
(10) Treatment is not suggested for longer than 2 weeks without evidence of compliance and significant demonstrated efficacy as documented by subjective and objective gains. (Note: Patients may get worse before they get better. For example, objective gains may be moving joints that are stiff from lack of use, resulting in increased subjective pain.) However, it is also not suggested that a continuous course of treatment be interrupted at two weeks solely to document these gains, if there are preliminary indications that they are being made on a concurrent basis.
(11) Integrative summary reports that include treatment goals, compliance, progress assessment with objective measures and stage of treatment, must be made available upon request at least on a bi-weekly basis during the course of the treatment program.
(12) Total treatment duration should generally not exceed 4 weeks (or the equivalent in part-day sessions if required by part-time work, transportation, childcare, or comorbidities). (Sanders, 2005) If treatment in excess of 4 weeks is required, a clear rationale for the specified extension and reasonable goals to be achieved should be provided. Longer durations require individualized care plans explaining why improvements cannot be achieved without an extension as well as evidence of documented improved outcomes from the facility (particularly in terms of the specific outcomes that are to be addressed).
(13) At the conclusion and subsequently, neither re-enrollment in repetition of the same or similar rehabilitation program (e.g. work hardening, work conditioning, out-patient medical rehabilitation) is medically warranted for the same condition or injury (with possible exception for a medically necessary organized detox program). Prior to entry into a program the evaluation should clearly indicate the necessity for the type of program required, and providers should determine upfront which program their patients would benefit more from. A chronic pain program should not be considered a “stepping stone” after less intensive programs, but prior participation in a work conditioning or work hardening program does not preclude an opportunity for entering a chronic pain program if otherwise indicated.
(14) Suggestions for treatment post-program should be well documented and provided to the referral physician. The patient may require time-limited, less intensive post-treatment with the program itself. Defined goals for these interventions and planned duration should be specified.
(15) Post-treatment medication management is particularly important. Patients that have been identified as having substance abuse issues generally require some sort of continued addiction follow-up to avoid relapse.
Inpatient pain rehabilitation programs: These programs typically consist of more intensive functional rehabilitation and medical care than their outpatient counterparts. They may be appropriate for patients who: (1) don’t have the minimal functional capacity to participate effectively in an outpatient program; (2) have medical conditions that require more intensive oversight; (3) are receiving large amounts of medications necessitating medication weaning or detoxification; or (4) have complex medical or psychological diagnosis that benefit from more intensive observation and/or additional consultation during the rehabilitation process. (Keel, 1998) (Kool, 2005) (Buchner, 2006) (Kool, 2007) As with outpatient pain rehabilitation programs, the most effective programs combine intensive, daily biopsychosocial rehabilitation with a functional restoration approach. If a primary focus is drug treatment, the initial evaluation should attempt to identify the most appropriate treatment plan (a drug treatment /detoxification approach vs. a multidisciplinary/interdisciplinary treatment program). See Chronic pain programs, opioids; Functional restoration programs. Also, see DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of multidisciplinary pain programs related to opioids.
Chronic pain programs, early intervention
Recommended, based on identification of patients that may benefit from early intervention via a multidisciplinary approach, as indicated below. The likelihood of return to work diminishes significantly after approximately 3 months of sick leave. It is now being suggested that there is a place for interdisciplinary programs at a stage in treatment prior to the development of permanent disability, and this may be at a period of no later than 3 to 6 months after a disabling injury. (Robinson, 2004) (Gatchel, 2003) (Jordan, 1998) Some early intervention programs have been referred to as “secondary treatment,” and differ from the more traditional, palliative care pain programs by not only the earlier onset of treatment, but by treatment intensity and level of medical supervision. (Mayer, 2003)
Recommendations for identification of patients that may benefit from early intervention via a multidisciplinary approach:
(a) The patient’s response to treatment falls outside of the established norms for their specific diagnosis without a physical explanation to explain symptom severity.
(b) The patient exhibits excessive pain behavior and/or complaints compared to that expected from the diagnosis.
(c) Risk factors are identified with available screening tools or there is a previous medical history of delayed recovery.
(d) The patient is not a candidate where surgery or other treatments would clearly be warranted.
(e) Inadequate employer support or evidence of work organizational factors limiting return to work without interventions.
(f) Evidence of psychosocial barriers that make return to work unlikely.
(g) Loss of employment or evidence of partial disability involving ability to perform only “part-time” work or work with “light-duty” restrictions for greater than 4 months. (Mayer, 2003) (Gatchel, 2003) For general information see Chronic pain programs.
Chronic pain programs, intensity
Recommend adjustment according to patient variables, as indicated below. Research is ongoing as to what treatments are most necessary as part of interdisciplinary treatment for patients with subacute and chronic pain, and how intense such delivery of care should be. The more traditional models of interdisciplinary pain management often provide what has been referred to as tertiary care; a more intensive, and often, more palliative treatment for chronic pain. Research as to the intensity of treatment that is required for earlier intervention remains ongoing (“secondary intervention” see Chronic pain programs, early intervention). Several examples show the difference in results based on intensity of treatment that occur based, in part, on variables such as gender, age, prognosis, diagnosis, and duration of pain. A recent study showed that for men with low back pain that had been “sick-listed” for an average of 3 months, there was no difference between extensive multidisciplinary treatment and usual care in terms of return to work. Significantly better results were found for men who received a “light treatment program” compared to usual care, and these results remained significant at 12, 18 and 24 months. (Skouen, 2002) On the other hand, an extensive program has been shown to be the most effective treatment modality for patients considered to be in categories of poor health, and poor prognosis who were “sick-listed” for the same period, although the effect tapers after one to two years. (Haldorsen, 2002) For general information see Chronic pain programs.
Chronic pain programs, opioids
Recommend assessing the effects of interdisciplinary pain programs on patients who remain on opioids throughout treatment, and to determine whether opioid use should be a screening factor for admission to or continuation in a program. Also see DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of multidisciplinary pain programs. The limited research that is available indicates that daily opioid use, in low doses, does not decrease effectiveness of chronic pain programs, although outcomes may be less optimal for patients who continue to use opioids. (Dersh, 2008) Current research indicates that simultaneous dependency/addiction programs with pain programs are a viable option. Some patients will require treatment of addictive disease before pain management can be effectively addressed. Patients with opioid dependence may require additional, long-term follow-up after the rehabilitation program. Criteria for this follow-up are still under research.
Programs that include detoxification as part of their protocol
PRIDE Program: In 2008 the PRIDE program (Progressive Rehabilitation Institute of Dallas for Ergonomics) (Dersh 2008) evaluated the role of post-injury opioid-dependence disorder (ODD) to assess if prescription opioid dependence (assessed at the beginning of rehabilitation) affected treatment outcome in patients with chronic disabling occupational spinal disorders. All patients with opioid dependence exhibited a lack of improvement or worsening in psychological well-being and social and vocational functioning despite the clinician’s best attempts at pain control. As noted, patients were required to taper off of all opioids early in treatment. Patients who had the following identified during initial treatment were referred to a facility psychiatrist (who had board certification in addiction): 1) evidence of use of high-dose/potency opioids or multiple opioids; 2) patients with a known history of current or lifetime substance-use disorders; 3) patients with known or easily apparent psychiatric disturbance; 4) patients that did not progress well in their detoxification under care of the attending physician. A diagnosis of substance dependence was made, in part, using the structured clinical interview for DSM-non-patient version (SCID-NP) and the SCID personality disorders (SCID-II). Prevalence of ODD was 15% on entering the program. ODD patients had greater length of disability (17 months for non-ODD vs. 29 months for ODD patients), were 2.5 times more likely to have had pretreatment surgery and 1.5 times more likely to be represented by an attorney. ODD patients were likely to have more axis I and II disorders (other than substance abuse disorders) than non-ODD patients. The odds ratio in ODD patients for current major depressive disorder was 1.7 and for current anxiety disorder was 1.7. ODD was significantly associated with preinjury substance-use disorders (O.R. 1.9). The substances identified included alcohol and drugs other than opioids. The axis II disorders associated with ODD were antisocial personality disorder and borderline personality disorder.
Results of program completers: Program completion was not significantly different between ODD and non-ODD patients. The primary reason for non-completion was non-compliance and treatment refusal and failure to develop a work plan. Only 5% of patients did not complete the program due to continued substance abuse/dependence. After adjusting for demographics and comorbid psychiatric disorders, opioid-dependent patients were 1.7 times less likely to return to work (95% confidence interval of this result was 1.0, 2.7, indicating a trend only). The opioid dependent patients were 2 times less likely to retain work at the 1-year interview (95% CI; 1.3, 3.0), and 1.7 times more likely to engage in healthcare utilization with new providers (95% CI; 1.2, 2.5). These rates were even higher when adjustment for comorbid psychiatric pathology was not made. (Dersh, 2007)
Detoxification and referral to an addiction specialist in this program: This program included detoxification from opioids early in the treatment program. Patients taking high-dose/potency opioids or multiple opioids, patients with a known history of current or lifetime substance-abuse disorders, patients with known or easily apparent psychiatric disturbance, and/or patients who did progress well with detoxification under care of the attending physician were referred to the facility psychiatrist (board certified in addiction). Patients that continued to use opioids were offered inpatient detoxification. If refused, they were discharged from the program. Assessments utilized: Structured clinical interview for DSM-non-patient versions (SCID-NP) to assess for axis I psychiatric disorders such as schizophrenia, depression and substance-use disorders and the SCID personality disorders (SCID-II) to assess for axis-II DSM personality disorders (Borderline, Antisocial, Paranoid).