Behavioral Treatment of Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00000398|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : November 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Coping skills training Behavioral: Physical exercise training Behavioral: Coping skills training plus physical exercise training||Phase 2|
Fibromyalgia (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. Traditional medical approaches to managing FM have limitations (side effects) and have not been effective in managing pain. Given these limitations, treatments that involve nonpharmacologic interventions may represent a valuable addition to patient care. This study will evaluate the effects of two of the most promising nonpharmacologic interventions for FM: coping skills training (CST) for pain management and physical exercise training.
The study is designed to test the hypothesis that an intervention that combines CST and physical exercise training will be more effective than CST or exercise alone. In this study, we will randomly assign each of 180 patients diagnosed with FM to one of four conditions: CST alone, physical exercise training alone, CST plus physical exercise training, or a waiting list control. We will evaluate study participants on four occasions: pre-treatment, post-treatment, 3-month followup, and 6-month followup.
The study will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness, self-effectiveness, and negative pain-related thoughts relate to improvements in pain and disability. Physicians could use this information in matching FM patients to treatment interventions. In addition, our findings may have implications for treatment selection for a broad range of patients suffering from persistent pain.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Behavioral Treatment of Fibromyalgia|
|Study Start Date :||July 1996|
|Estimated Study Completion Date :||June 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000398
|United States, Ohio|
|Athens, Ohio, United States, 45701|
|Ohio State University|
|Columbus, Ohio, United States, 43221|
|Principal Investigator:||Christopher France, PhD||Ohio University|