|
Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention conditions. Clinical Trials Search.org is a site dedicated 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 healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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 allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention clinical trial. Participants typically obtain the most effective healthcare available for their Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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. Compare the Medical Conditions of Gulf War Veterans to Non-Deployed Veterans
2. Support, Health, and Fibromyalgia
3. Behavioral Treatment of Fibromyalgia
4. Behavioral Insomnia Therapy for Fibromyalgia
5. Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Related Studies:
Other Fibromyalgia Clinical Trials
Other Clinical Trials
Other Clinical Trials
Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
|
|
|
|
|
|
|
|
