Fibromyalgia (FM) is one of the most common rheumatic diseases affecting six million Americans and up to 20 percent of patients seen in rheumatology practices. FM is characterized by diffuse musculoskeletal pain, discrete tender points at typical soft-tissue sites, fatigue, stiffness, and sleep problems. Of these symptoms, pain is often the primary concern of FM patients and their physicians. FM patients have increased pain when they attempt to exercise or engage in daily activities and, as a result, often decrease their activity. Traditional medical approaches to managing FM have limitations (side effects) and have not been effective in managing pain. Given these limitations, treatments that involve non-pharmacologic interventions may represent a valuable addition to patient care. The proposed study seeks to evaluate the effects of two of the most promising non-pharmacologic interventions for FM: cognitive behavioral therapy (CBT) for pain management and physical exercise training. The study is designed to test the hypotheses that an intervention that combines CBT and physical exercise training will be more effective than CBT or exercise alone. In this study, 180 patients diagnosed with FM will be randomly assigned to one of 4 conditions: cognitive behavioral therapy (CBT) for pain management, CBT plus - physical exercise training, physical exercise training alone, or waiting list control. The study: 1) will evaluate whether CBT plus physical exercise training is more effective in reducing pain, tender point pain threshold, psychological distress, physical disability, fatigue, and pain behavior than CBT or exercise training alone, 2) will determine how changes in aerobic fitness, self efficacy, and the frequency of negative pain related thoughts relate to long-term (9 months) improvements in pain and disability, and 3) will use newly developed daily study methods to analyze the long-term effects of the interventions on daily pain coping. If CBT and exercise interventions have synergistic effects in FM patients, future studies could evaluate this combination in other rheumatic disease patients (e.g., rheumatoid arthritis or lupus) or in stroke or burn injury patients who are having pain during exercise/rehabilitation regimens. Future studies also could test the efficacy of home based CBT-exercise programs. Research could be carried out to identify the components of CBT (e.g., cognitive restructuring) and physical exercise training (e.g., cardiovascular or muscular endurance training) that contribute most to treatment effects. By isolating active ingredients responsible for change, one can tailor CBT and exercise interventions so as to maximize their effects. This study will reveal how individual differences in aerobic fitness, self-efficacy, negative thinking, and daily coping are related to improvements in pain and physical and psychological functioning. This information could be used in matching FM patients to treatment interventions, and may have implications for treatment selection for a broad range of patients suffering from persistent pain.
| Keefe, F J; Lumley, M; Anderson, T et al. (2001) Pain and emotion: new research directions. J Clin Psychol 57:587-607 |
| Keefe, F J; Bonk, V (1999) Psychosocial assessment of pain in patients having rheumatic diseases. Rheum Dis Clin North Am 25:81-103 |
| Sandstrom, M J; Keefe, F J (1998) Self-management of fibromyalgia: the role of formal coping skills training and physical exercise training programs. Arthritis Care Res 11:432-47 |
| Keefe, F J; Caldwell, D S (1997) Cognitive behavioral control of arthritis pain. Med Clin North Am 81:277-90 |
