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Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention Clinical research trials and Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention. Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention clinical trial. Subjects often receive the most expert healthcare possible for their Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention  Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
For Condition: Fibromyalgia
Status: Completed
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The goal of this proposal is to evaluate the efficacy of a multiple component mind-body (MCMB) therapy for fibromyalgia, both in short and long term outcomes. Preliminary work suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al 1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week education/attention intervention. The primary aims of this study are 1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks) outcomes in FM patients compared to an education/attention control group; and 2) to determine if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients compared to an education/attention control group. A secondary aim of this project involves determining if there are patient characteristics (i.e. disease severity and duration, demographics, psychological factors) associated with improvements in short or long term outcomes as well as responses to the MCMB intervention. The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire.
Details: Fibromyalgia (FM) is a common, complex and chronic condition of unknown etiology (Carette 1994). It is characterized by widespread musculoskeletal pain, multiple tender points, fatigue and a range of other symptoms (Wolfe 1990). FM accounts for 15% of rheumatology consultations, with a prevalence of 2% in the general population (3.4% in females and 0.5% in males), rising to 7% in the elderly females (Wolfe 1995). Disability levels in social and work roles, as well as use of medical care, is high. Current treatment options often meet with limited success. The goal of this proposal is to evaluate the efficacy of a multiple component mind-body (MCMB)therapy for fibromyalgia, both in short and long term outcomes. Preliminary work suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al 1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB intervention or a 12 week education/attention intervention. The primary aims of this study are (1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks) outcomes in FM patients compared to an education/attention control group; and (2) to determine if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients compared to an education/attention control group. A secondary aim of this project involves determining if there are patient characteristics (i.e. disease severity and duration, demographics, psychological factors) associated with improvements in short or long term outcomes as well as responses to the MCMB intervention. The primary outcome measure will include physical functioning and pain as measured by the Fibromyalgia Impact Questionnaire.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Clinical diagnosis of fibromyalgia by patient's own health care provider - ACT classification of fibromyalgia verified by rheumatological examination: a) widespread pain (axial plus upper and lower segment plus left-and-right-sided pain for 3 months or longer; b) tenderness at 11 or more of the 18 specific tender point sites - Read and speak English fluently - Be able to attend group intervention session if assigned to that group - Able to give informed consent Exclusion Criteria: - Pregnancy - Substance abuse - Major psychiatric disorder (that would prevent compliance) - Involvement in impending litigation or judgment for disability workmen's compensation - Uncontrolled hypertension, uncontrolled diabetes, congestive heart failure or other severe chronic medical conditions judged by the clinician to place the patient at risk of possible severe consequences of their disease.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Dr.Berman, Principal Investigator, Univ. of Maryland/Complementary Medicine Program
Additional Information:
Study ID Numbers: 1 P50 AT00084-01P2; 1 P50 AT00084-01
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010777
Other Fibromyalgia Studies:
1. Efficacy of Acupuncture in the Treatment of Fibromyalgia
2. Behavioral Insomnia Therapy for Fibromyalgia
3. Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
4. Eligibility Screening for National Institute of Dental and Craniofacial Research Studies
5. Assessing Fibromyalgia Treatments
Related Studies:
Other Fibromyalgia Clinical Trials
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Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
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