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Sponsored by: |
National Institutes of Health (NIH) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00762125 |
Fibromyalgia syndrome (FMS) refers to a set of symptoms that include exhaustion, muscle pain, and tender points, where slight pressure can cause pain. Doctors do not know what causes FMS or how to cure it, but some treatments have helped relieve its symptoms. Progressive exercise, in which exercise is started at low levels and then increased, is one of the most reliable treatments, but people with FMS often avoid exercise or stop after completing exercise programs. This research will focus on the idea that people with FMS do not exercise because they are afraid of injury or have had a negative experience exercising. Participants will undergo one or a combination of several different treatments that aim to reduce fear of exercising. The different treatments will then be evaluated on their effectiveness in reducing disability among people with FMS.
Condition | Intervention | Phase |
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Fibromyalgia |
Behavioral: CR+ST Behavioral: ET Behavioral: AC treatment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment |
Official Title: | Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment |
Estimated Enrollment: | 235 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cognitive restructuring and coping skills training (CR+ST): Experimental |
Behavioral: CR+ST
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
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Exposure therapy (ET): Experimental |
Behavioral: ET
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
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Combination (COMB) treatment: Experimental |
Behavioral: CR+ST
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
Behavioral: ET
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
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Attention control (AC) treatment: Active Comparator |
Behavioral: AC treatment
Provides support and controls for nonspecific factors associated with exposure to therapists and other FMS sufferers, but does not directly address either maladaptive beliefs or emotional arousal
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Fibromyalgia syndrome (FMS) is a condition without a known cause or cure. Differing theories place the blame on abnormal sensitivity to pain receptors in the brain, changes in metabolism and hormones, abnormalities in the autonomic nervous system, sleep disturbances, infection, or injury. A diagnosis of FMS, therefore, is based on a set of symptoms. These include pain in muscles, ligaments, and tendons; fatigue; and multiple tender points on the body, where even slight pressure causes pain.
Although there is no cure, FMS can be treated to reduce the severity or presence of symptoms. One of the most reliable ways to do this is through progressive exercise, which involves starting at low levels of exercise and building up to longer and more strenuous levels. Despite the benefit of exercise, FSM sufferers often drop out of supervised exercise programs or discontinue exercise once they are no longer supervised. Some FMS patients may have a fear-based avoidance of exercise, believing it will provoke pain or deterioration of their condition and experiencing significant negative emotional arousal when they exercise. This may be due to a prior painful or uncomfortable experience while exercising.
This study will employ multiple treatments that are usually used for treatment of phobias and will aim to reduce fear, increase exercising, and improve FMS symptoms. Under the purview of cognitive behavioral therapy (CBT) are multiple types of treatments. Cognitive restructuring (CR) and coping skills training (ST) paired together address maladaptive beliefs and facilitate the development of more effective coping strategies. Exposure therapy (ET) reduces the level of emotional arousal when patients are exposed to the feared stimulus, in this case exercising. Attention control (AC) treatment, not a type of CBT, provides patients with support and controls for nonspecific factors related to exposure to their feared stimulus. AC will be used as the control treatment in this study.
Participation in this study will last 4 months. After recruitment and an initial evaluation, participants will be placed on a waiting list for 8 weeks to determine whether their symptoms improve or change naturally. They will then be reassessed and randomly assigned to one of the following groups for 8 weeks of treatment:
Participants will undergo a series of assessments that include self-report measures, medical and psychological evaluations, and a physical capability evaluation by a physical trainer. These assessments will be performed at recruitment, after the 8-week waiting period, after treatment, at 1- and 3-month mail and telephone follow-ups, and at a 6-month follow-up in the treatment clinic. They will assess fear, health, physical ability, and psychological health.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nicholas Lazarakis | 206-221-5146 | lazarn@u.washington.edu |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98115 | |
Contact: Nicholas Lazarakis 206-221-5146 fibroctr@u.washington.edu |
Principal Investigator: | Dennis C. Turk, PhD | University of Washington |
Responsible Party: | Department of Anesthesiology, University of Washington ( Dennis C. Turk, PhD ) |
Study ID Numbers: | R01 AR044724-07 |
Study First Received: | September 26, 2008 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00762125 History of Changes |
Health Authority: | United States: Federal Government |
Fibromyalgia Syndrome FMS Physical Therapy Psychotherapy |
Group Counseling Individual Counseling Chronic Pain |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Pathologic Processes Disease Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Myofascial Pain Syndromes Fibromyalgia Syndrome Nervous System Diseases Rheumatic Diseases |