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CNS Spectr. 2009;14:12(Suppl 16):10-12
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Mount Sinai School of Medicine and MBL Communications, Inc. The Mount Sinai School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Credit Designation
The Mount Sinai School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 CreditsTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Faculty Disclosure Policy Statement
It is the policy of the Mount Sinai School of Medicine to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.
Statement of Need and Purpose
Fibromyalgia (FM) is the most common chronic pain syndrome encountered in general medicine, estimated to affect 5 million American adults. FM involves multiple clinical domains, including pain, fatigue, sleep disturbances, depression, and cognitive impairment. Patients with FM report significant negative impact of the illness on social and occupational function and overall quality of life. Society bears a substantial disease burden associated with FM, not only in direct health care costs but also in productivity loss to employers. Much progress has been made in understanding FM, yet management of the condition continues to confound physicians and frustrate patients. The complex interactions between neurobiological, psychological, and functional/behavioral components of FM as well as the poor response of patients to conventional pain therapies have proven particularly challenging. Research has shown that a multimodal management program yields the most benefit to patients. To implement this multimodal treatment paradigm, physicians—including primary care physicians, neurologists, and psychiatrists—need clear direction regarding the diagnosis of FM, available pharmacologic and non-pharmacologic interventions, and clinical application.
Learning Objectives
At the completion of this activity, participants should be better able to:
• Utilize the diagnostic criteria for fibromyalgia (FM) based on the current biochemical and neurophysiological understanding of its etiology
• Assess the clinical domains affected by FM and their impact on health-related quality of life
• Analyze the clinical evidence supporting the use of pharmacologic and non-pharmacologic intervention in the treatment of FM and the putative advantages of each agent
• Integrate available therapy options to develop evidence-based multidimensional treatment plans for patients with FM
Target Audience
This activity is designed to meet the educational needs of neurologists.
Faculty Affiliations and Disclosures
Roland Staud, MD, professor of medicine in the Division of Rheumatology and Clinical Immunology, McKnight Brain Institute, at the University of Florida in Gainesville. Dr. Staud is a consultant to Jazz and has received honoraria from Forest and Jazz.
Philip J. Mease, MD, is chief of Rheumatology Clinical Research at Swedish Medical Center, and clinical professor at the University of Washington School of Medicine, both in Seattle. Dr. Mease is a consultant to, an independent contractor for, and has received research support from Allergan, Boehringer-Ingelheim, Cypress, Eli Lilly, Forest, Jazz, Pfizer, and Wyeth; and is on the advisory board and has received honoraria from Cypress, Forest, Pfizer, and Wyeth. Dr. Mease discusses unapproved/experimental uses of gabapentin, tricyclic antidepressants, and analgesics for the treatment of fibromyalgia.
David A. Williams, PhD, is professor of anesthesiology and medicine (rheumatology), professor of psychiatry and psychology, and associate director of the Chronic Pain and Fatigue Research Center at the University of Michigan in Ann Arbor. Dr. Williams is a consultant to Eli Lilly, Forest, and Pfizer.
CME Course Director James C.-Y. Chou, MD, is associate professor of psychiatry at Mount Sinai School of Medicine. Dr. Chou has received honoraria from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, and Pfizer.
Stelian Serban, MD, is assistant professor of anesthesiology and director of acute and chronic inpatient pain service in the Department of Anesthesiology at Mount Sinai School of Medicine in New York City. Dr. Serban reports no affiliation with or financial interest in any organization that may pose a conflict of interest.
Activity Review Information
The activity content has been peer-reviewed and approved by Stelian Serban, MD.
Review Date: December 14, 2009.
Acknowledgment of Commercial Support
Funding for this activity has been provided by an educational grant from Pfizer Inc.
To Receive Credit for this Activity
Read this Expert Review Supplement, reflect on the information presented, and complete the CME posttest and evaluation on pages 15 and 16. To obtain credit, you should score 70% or better. Early submission of this posttest is encouraged. Please submit this posttest by December 1, 2011 to be eligible for credit.
Release date: December 31, 2009
Termination date: December 31, 2011
The estimated time to complete this activity is 2 hours.
Fibromyalgia FACTS Web Initiative
This Expert Review Supplement is the first stage of the Fibromyalgia FACTS Initiative. In January, look for a link to the Fibromyalgia FACTS Web site at www.cnsspectrums.com to find new CME-certified case study presentations, an Ask-the-Experts forum where you can submit your questions to the faculty, and a list of helpful resources.
Dr. Williams is professor of anesthesiology and medicine (rheumatology), professor of psychiatry and psychology, and associate director of the Chronic Pain and Fatigue Research Center at the University of Michigan in Ann Arbor.
Disclosures: Dr. Williams is a consultant to Eli Lilly, Forest, and Pfizer.
Introduction
The optimal management of fibromyalgia (FM) is comprised of both pharmacologic and nonpharmacologic approaches. This multidimensional approach is preferred given that FM is not only a pain condition, but involves a number of other symptoms as is reflected in the new clinical criteria being developed by Wolfe and colleagues.1 Proper management of FM should be informed through multi-dimensional assessment of the clinically relevant domains described previously in this supplement. Pharmacologic and nonpharmacologic approaches work together to provide the broadest possible coverage of these domains, minimize the impact of each domain on functioning and well-being, and facilitate long-term adaptations to one’s lifestyle.
Nonpharmacologic Strategies: Evidence of Efficacy
The use of nonpharmacologic strategies in the management of FM has varying levels of evidence. The strongest evidence currently exists for aerobic exercise, cognitive-behavioral therapy (CBT), and for patient education or self-management. Moderate evidence exists for strength training, acupuncture, hypnotherapy, and biofeedback modalities. Weaker evidence exists for manual massage therapy.2-6 Currently, there is no evidence of long-term benefit for tender point injections7 or flexibility exercise modalities,2-6 although these options may be beneficial in the short term. This article will focus on the three areas that have the strongest evidence base: patient education, exercise, and CBT.
Patient Education
Educational programs are typically offered in the context of primary care or in specialty practices. In their simplest form, these programs try to dispel myths about FM and provide patients with the most up-to-date knowledge about the condition. Beyond this information, clinicians can encourage patients to begin or to increase exercise as well as to engage in self-management lifestyle adaptations, such as becoming more involved socially and increasing activity levels. Most educational programs also emphasize the important role of the patient in actively participating in the management of persistent pain.
Overall, educational programs have been of great value and the evidence to date supports favorable outcomes.8 In some cases, most of the management of FM can be performed on an educational and self-management basis along with the guidance and encouragement of the primary care provider. Education/self-management may not be sufficiently comprehensive or robust for every patient however, and additional modalities will be needed. This approach tends to work best with highly motivated patients.
Exercise
Exercise is another nonpharmacologic approach with known benefits for FM. Exercise would include activities such as aerobic exercise, water aerobics, and simple monitoring of, and the taking advantage of, exercise occurring in the context of conducting one’s daily routine. Aerobic exercise at moderate intensity has been shown to improve overall well-being as well as physical functioning in patients with FM.5 While the data supporting exercise in FM is encouraging, enthusiasm is a bit tempered by the relatively high attrition rates in current studies (ie, 13% to 44%),5 and the tendency for poor adherence long-term. Another type of exercise, strength training, has also been associated with decreased pain, improvements in tender points, and improvements in depression and overall well-being,5 but more high quality studies should be conducted in this area.
Cognitive-Behavioral Therapy
One of the more effective nonpharmacologic interventions is CBT.3 Despite its demonstrated efficacy, CBT may also be the least likely intervention to be used clinically, due in part to a lack of qualified providers in many clinical settings. At its core, CBT aims to identify and modify maladaptive behavior and thinking patterns. Such behaviors and thinking patterns often emerge naturally when a patient tries to deal with acute pain. For example, when a patient experiences acute pain, engaging in certain behavioral patterns may actually reduce pain in the short-term; such as limiting movement to an injured area or cutting back on physical and social activities. Although such behavioral patterns can be effective in the management of acute pain, FM by definition is a chronic pain condition. Thus, these initial adaptive responses to acute pain can become maladaptive if adopted over the long term. The purpose of CBT is to identify such behavioral patterns and assist patients in learning new behaviors and thinking styles that are more conducive to living with chronic pain over time.
The work involved in CBT is not simple or easy and requires a sound therapeutic alliance between the patient and the clinician providing CBT. In this alliance, patients are responsible for identifying the symptoms they wish to address as well as the desired outcomes they hope to achieve. Realistic goal setting is often a part of this process. Patients are also responsible for learning new skills for making changes in behavior or thinking patterns as well as implementing these solutions over time. The therapist also has responsibilities including being an active listener to patients’ concerns and desires, helping patients to define goals, teaching the skills of adaptation, tailoring the skills to the individual, and supporting progress at each step along the way. A wide variety of skills exist that can be applied to helping patients learn new behaviors and new ways of thinking in service of better pain management.
CBT Skills
The most common CBT skills used in the management of FM are ones that promote the relaxation response, behavioral sleep strategies, graded activation, and pleasant activity scheduling (Slide 1).9 Each of these skills directly impact specific symptoms that are experienced in the context of FM. For example, learning the relaxation response (eg, progressive muscle relaxation, visual imagery) has shown positive effects on decreasing pain and improving sleep.9 Behavioral sleep strategies, which often involve regimented sleeping and waking patterns, good sleep hygiene, and maintenance of an environment conducive to sleep, have been beneficial in addressing the common problem of sleep disturbance in FM. In addition, behavioral sleep interventions can also impact other symptoms including dyscognition and fatigue.9
Many patients with FM report giving up most of the activities that previously brought pleasure into their lives. Typically, they now only participate in essential daily tasks. Obviously, this change can impact mood, which in turn, can worsen pain. In CBT, patients are encouraged to schedule pleasant activity into their day as they would schedule a doctor’s appointment. Scheduled activity is preferable as it is more likely to happen and can be planned. Planned activities are usually safer and tend to unfold more predictably than spontaneous activities, which carry the risk of overexertion and pain flare-ups. The therapist may suggest that patients keep a calendar in order to ensure that there will be opportunities throughout the day and throughout each week where pleasant activities can occur, thus providing opportunities for improved mood. For individuals with low functional levels, engaging in pleasant activities may need to be paired with another behavioral strategy: graded activation. Graded activation helps patients gradually improve their activity level through the use of time-based pacing. Pacing based upon time rather than upon the completion of tasks again helps to prevent the occurrence of pain flare-ups in both pleasant and required daily tasks.
While each of these skills can be challenging to learn, it can also be challenging to implement these skills into one’s lifesyle over the long term. Thus, lifestyle changes may be required in order to eliminate barriers to change. For example, a patient may learn how to use relaxation strategies, but find it difficult to incorporate these strategies over the long term due to competing time demands from family or work. Thus, there are a set of CBT interventional skills to assist with the long-term integration of behavioral and thinking changes. These skills include stress management, goal-setting strategies, structured problem-solving approaches, and reframing—a skill that teaches patients to challenge unhelpful thinking styles. Lastly, communication skills both between patients and their families (who may be unwittingly hindering adaptation) and between patients and their health care providers can facilitate more effective long-term management of FM.
CBT has been studied in several randomized controlled trials for FM. Williams and colleagues3 used a brief form of CBT that involved only six, 1-hour group sessions. As compared to their baseline scores, patients in treatment with brief CBT showed significant improvement in physical functional status that was sustained 12 months later (Slide 2).3 In this study, the authors were investigating cognitive-behavioral skills that specifically targeted physical functioning status (often a more challenging domain to improve than is pain). Another randomized controlled trial examined CBT and operant behavioral therapy, which is similar to CBT but does not include cognitive components. As with the previous study, physical functioning was found to be significantly improved compared to the control group.10 In addition, patients receiving either active intervention also showed improvements in pain long term (Slide 3).10
Hybrid Nonpharmacologic Treatment Approaches: Web-Enhanced Behavioral Self-Management Programs
Despite supporting empirical evidence, CBT and exercise remain underutilized in actual clinical practice. As a means of addressing some of the barriers to access, Web-enhanced behavioral self-management programs are starting to emerge. By utilizing the Internet, it becomes possible to create a hybrid form of nonpharmacologic care that incorporates CBT principles and approaches to exercise within educational programs that can be delivered at distance.
The information contained in these programs come from empirically sound sources and are crafted and delivered by qualified experts in each concept. The program can be used effectively as a stand-alone self-management intervention (eg, where patients have no therapist other than their usual primary care provider), or these approaches can be combined with office-based or mid-level providers who can provide individualized tailoring or coaching based upon the Web site’s standardized content. An example of one of these programs is called FibroGuide, a site providing empirically-supported content that is available to the public.11 FibroGuide was based on an earlier program named Living Well with Fibromyalgia developed at the University of Michigan that was evaluated in the context of a randomized controlled trial for efficacy. Both programs illustrate how nonpharmacologic symptom management, using the previously-described skills, can be effectively delivered over the Web and meaningfully integrated into primary care or specialty clinic practice at little cost.
Conclusion
Dually-focused interventions for the management of FM are necessary given the wide range of symptoms associated with the condition. Pharmacologic interventions can work synergistically with nonpharmacologic approaches to provide patients with the broadest possible coverage addressing each of the clinically relevant symptom domains. Difficulties integrating evidenced-based interventions, such as education, exercise, and CBT, into routine care for FM are being partially addressed by newer Web-based educational media. It is hoped that a more complete and empirically supported approach to the management of FM will soon be possible virtually anywhere for patients seeking care for this condition.
References
1. Wolfe F, Clauw DJ, Fitzcharles MA, et al. Clinical Diagnostic and Severity Criteria for Fibromyalgia. Paper presented at: the 73rd Annual Scientific Meeting of the College of Rheumatology/Association of Rheumatology Health Professionals; October 18, 2009; Philadelphia, PA.
2. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004;292(19):2388-2395.
3. Williams DA, Cary MA, Groner KH, et al. Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention. J Rheumatol. 2002;29(6):1280-1286.
4. Karper WB, Jannes CR, Hampton JL. Fibromyalgia syndrome: the beneficial effects of exercise. Rehabil Nurs. 2006;31(5):193-198.
5. Busch A, Schachter CL, Peloso PM, Bombardier C. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2002;(3):CD003786.
6. Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol Suppl. 2005;75:6-21.
7. Staud R. Are tender point injections beneficial: the role of tonic nociception in fibromyalgia. Curr Pharm Des. 2006;12(1):23-27.
8. van Koulil S, Effting M, Kraaimaat FW, et al. Cognitive-behavioural therapies and exercise programmes for patients with fibromyalgia: state of the art and future directions. Ann Rheum Dis. 2007;66(5):571-581.
9. Williams DA. Cognitive and behavioral approaches to chronic pain. In: Wallace DJ, Clauw DJ, eds. Fibromyalgia and Other Central Pain Syndromes. Philadelphia, PA: Lippincott Williams & Wilkins; 2005.
10. Thieme K, Turk DC, Flor H. Responder criteria for operant and cognitive-behavioral treatment of fibromyalgia syndrome. Arthritis Rheum. 2007;57(5):830-836.
11. FibroGuide. Available at: www.knowfibro.com/fibroguide.jsp. Accessed November 24, 2009.
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