Fibromyalgia and Pain Management

Chronic pain, usually defined as pain lasting 3 months or longer, occurs commonly, affecting approximately 15% of the general population.¹ Fibromyalgia, a pain syndrome that is chronic, widespread, nonarticular, and often accompanied by other symptoms including fatigue, stiffness, and sleep disturbance, accounts for a significant percentage of patients with chronic pain. Approximately 2% to 4% of individuals in the general population have fibromyalgia. The diagnosis typically is made in adults between the ages of 20 and 60 years. Women are affected more often than men and account for the majority of cases.² Fibromyalgia is the second most common referral diagnosis in rheumatology clinics after osteoarthritis, accounting for one-third of all referrals.³

Though fibromyalgia is commonly seen in both primary care and subspecialty settings, there is ample evidence that healthcare professionals in general are uncomfortable and unfamiliar with the diagnosis and management of this condition.⁴ Family physicians should be prepared to distinguish fibromyalgia from other chronic pain conditions and use patient education, pharmacotherapy, and lifestyle changes to help their patients with this chronic condition.

Because pain, including chronic pain, is a heterogeneous symptom, a standardized approach to diagnosis is not appropriate. There are, however, important concepts and principles family physicians should know when evaluating patients with chronic pain. These four pain categories are useful for characterizing chronic pain⁵:

It is possible for one condition to cause more than one type of chronic pain. Pain should not be evaluated in isolation from other important aspects of the clinical context (eg, a patient with musculoskeletal pain may present with pain and a limp). Treatment will vary considerably depending on pain etiology and severity. Though these principles apply to chronic pain generally, the diagnosis of fibromyalgia is complicated and deserves special attention for several reasons. Pain in fibromyalgia is widespread and not limited to one part of the body. Laboratory tests are useful in ruling out other conditions, but a definitive diagnosis of fibromyalgia cannot be made based on these test results. Fibromyalgia is often accompanied by other conditions, including mood disorders, which affect 6% to 35% of fibromyalgia patients.^6,7 Finally, a diagnosis of fibromyalgia carries significant stigma, and dismissive attitudes toward the condition are common in society and the medical community.⁸ It takes affected individuals an average of 5 years to receive an accurate diagnosis, often after seeing multiple physicians.⁹

In 1990, the American College of Rheumatology (ACR) put forth criteria for the diagnosis of fibromyalgia. These criteria are tenderness on pressure in at least 11 of 18 specific anatomic sites (ie, tender points) and widespread pain (ie, axial pain, left- and right-sided pain, upper- and lower-body pain).¹⁰ These criteria proved useful in research and other specialized settings but have significant shortcomings, especially in the primary care setting. Most primary care physicians are unfamiliar with and unwilling to perform tender-point examinations.^11,12 Also, males require greater tender-point pressure to perceive tender points as painful than do females. Fibromyalgia is frequently underdiagnosed in men.¹³

Most importantly, the 1990 ACR criteria did not consider important symptoms of fibromyalgia such as fatigue and sleep disruption. For these reasons, the ACR has developed a set of preliminary diagnostic criteria for fibromyalgia that do not rely on tender-point examination and that account for the effects and severity of the condition (Figure).¹⁴ These new criteria are not intended to replace the original 1990 criteria, which remain the gold standard. The new criteria were developed by extracting useful diagnostic variables in a multicenter study of 829 fibromyalgia patients and control subjects. Symptoms satisfy the new diagnostic criteria if three conditions are met:

An advantage of the questionnaires based on the new criteria is that they can be completed by patients. The new criteria also can be used to monitor severity and response to treatment over time.

Based on a review of the evidence and focus groups with patients, the Institute for Clinical Systems Improvement (ICSI) developed a detailed guideline for assessment and management of chronic pain.⁵ Among the principal recommendations is a plan of care for all chronic pain patients that includes setting personal goals, improving sleep, increasing physical activity, managing stress, and decreasing pain.

Key ICSI recommendations applicable in the primary care setting for managing chronic pain include incorporating exercise and assessing and managing mental health comorbidities, including depression. ICSI recommends that primary care physicians use these initial cognitive behavioral strategies:

A variety of pharmacologic agents is used to treat chronic pain, but drugs alone will not control the pain associated with fibromyalgia. Drugs include anti-inflammatories, tricyclic antidepressants, anticonvulsants, and opioids.

The general principles of chronic pain management also apply to patients with fibromyalgia, including the development of a care plan that includes nonpharmacologic and pharmacologic therapies. Following is a discussion of effective nonpharmacologic management strategies and a systematic approach to drug therapy.

Education. One randomized controlled trial that involved 207 patients showed that education in the form of a fibromyalgia self-help course (examples can be found at http://www.cfidsselfhelp.org/online-courses) in combination with exercise is more effective in relieving symptoms than exercise alone.¹⁵ Education about fibromyalgia should therefore be included in every patient’s care plan.

Exercise and Balneotherapy. Many studies have shown the benefits of exercise for fibromyalgia.¹⁶ Many types of exercise have been shown to be effective, including aerobic conditioning, flexibility training, and strength training. Furthermore, heated pool treatment (ie, balneotherapy, or spa therapy) has been shown to be effective with or without exercise.¹⁷

Cognitive Behavioral Therapy and Operant Behavioral Therapy. Cognitive behavioral therapy (beyond the initial steps described heretofore and often including relaxation therapy) and operant behavioral therapy (which emphasizes increased activity, inclusion of significant others to reduce reinforcement of pain behaviors, and reduction of pain-contingent drugs) have been shown to be effective in reducing symptoms. These therapies can be offered to patients if available.

Alternative Therapies. Alternative therapies are frequently pursued for relief of fibromyalgia symptoms. German guidelines for alternative treatments recommend meditative movement therapies (eg, tai chi, yoga) and acupuncture.¹⁸ The ICSI also recommends acupuncture for fibromyalgia based on high-quality evidence.⁵ Herbs and supplements have been evaluated in small studies, but more evidence is needed before their use can be recommended.¹⁹

Many pharmacologic therapies are available for management of fibromyalgia. All such therapies should only be prescribed as part of a comprehensive treatment plan that includes education and nonpharmacologic therapies. An extensive systematic review classified drugs by efficacy for pain and effect on psychological function using these criteria: strong evidence, modest evidence, weak evidence, and no evidence (Table).²⁰ Though this review was published more than 8 years ago, the classification framework and much of the underlying evidence reviewed is still useful. Only three drugs, duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica), are approved by the Food and Drug Administration for management of fibromyalgia, though others are used off-label with good results. Recent evidence suggests that individuals with fibromyalgia have fewer opioid receptors than those without the condition.²¹ Though opioids are frequently prescribed, they should be avoided in the treatment of patients with fibromyalgia.

Guidelines and algorithms for pharmacologic management of fibromyalgia are available. These guidelines evaluate the strength of evidence underlying particular drugs at the time they were published rather than providing an algorithm for treatment. The algorithms emphasize only the three FDA-approved drugs as initial treatment.^20,22

The choice of initial treatment depends on a number of factors including the type and severity of symptoms, comorbid psychosocial conditions, and tolerance of adverse effects. A reasonable, initial approach is to begin with low-dose (25 mg) amitriptyline or cyclobenzaprine (10 mg) as part of a comprehensive treatment plan. The dose can be increased gradually and modestly, depending on the response. Most therapeutic drug trials for fibromyalgia have lasted at least 6 to 12 weeks. If the response to initial therapy is unsatisfactory within that time, a different class of drug can be tried, either as an alternative or as an adjunct to initial therapy.

If prescribed and used appropriately and responsibly, opioids can be highly effective for some types of chronic pain, but not fibromyalgia. Opioids are generally used after other alternatives have proven ineffective. The same physician should prescribe opioids and monitor their use. An opioid assessment tool can help identify patients who are appropriate candidates for long-term opioid treatment. There are many examples of these tools. The Opioid Risk Tool (ORT) is available at http://www.partnersagainstpain.com/printouts/Opioid_Risk_Tool.pdf.

The Federation of State Medical Boards (FSMB) has developed a model policy for the use of controlled substances to manage pain. The policy recommends thorough evaluation of the patient, use of a written treatment plan, periodic review of pain management, appropriate referral/consultation, maintenance of complete and accurate medical records, compliance with all controlled substance laws and regulations, and obtaining informed consent for treatment. Informed consent should specify how opioids and other controlled substances will be prescribed and their use will be monitored. This includes the number and frequency of prescription refills that will be provided, reasons why pharmacologic therapy can be discontinued (eg, violation of agreement specified in the consent), and drug screening to monitor for appropriate use and simultaneous use of drugs of abuse.²³

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