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Support, Health, and Fibromyalgia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Support, Health, and Fibromyalgia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Support, Health, and Fibromyalgia Clinical research trials and Support, Health, and Fibromyalgia health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Support, Health, and Fibromyalgia. Support, Health, and Fibromyalgia Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Support, Health, and Fibromyalgia clinical trial. Human subjects often get the best healthcare possible for their Support, Health, and Fibromyalgia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Support, Health, and Fibromyalgia  Support, Health, and Fibromyalgia
Support, Health, and Fibromyalgia
For Condition: Fibromyalgia,Quality of Life
Status: Completed
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. We randomly assigned the study participants to one of three groups. People in the social support group met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The social support and education group also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS. Members of this group learned about the disease and ways they can manage it themselves. The third group participated only in the five assessment periods. The study lasted 4 years.
Details: Next to osteoarthritis, FMS is the most common arthritis-related disease. Symptoms include musculoskeletal pain, fatigue, headaches, irritable bowel syndrome, morning stiffness, and sleep disturbances. Fluctuating severity, pain, and frustration with the difficulty of diagnosis and treatment lead patients to continually seek help from health care professionals. There is no known cause or cure for this disease. This study tests the effects of social support and education on the health and well-being of people with fibromyalgia (FMS). We recruited 600 adults with a confirmed diagnosis of FMS from a large health maintenance organization. To be eligible, people had to meet the American College of Rheumatology guidelines for FMS. After we confirmed the diagnosis, we assigned those who agreed to participate to one of three groups. The first group (social support) met with others who suffer from FMS for 2 hours every week for 10 weeks, and then monthly for an additional 10 months. The second group (social support and education) also had 10 2-hour weekly meetings followed by 10 monthly meetings with others who suffer from FMS, and its members learned about the disease and self-management techniques. The third group (control) participated only in the five assessment periods. We assessed people in all three groups before we assigned them to a group, after the intervention, and at yearly follow-ups. The study duration was 4 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - A diagnosis of fibromyalgia documented in medical records and confirmed using The American College of Rheumatology criteria for classification of FMS: (1) A history of widespread pain (pain on both sides of the body, above and below the waist, and present for at least 3 months). (2) Pain in 11 or more of 18 tender-point sites. - Patient willing to attend 10 weekly meetings and 10 monthly meetings. Exclusion Criteria: - Patients who do not meet ACR criteria for FMS described above. - Patients who cannot attend meetings once a week for 10 weeks and once a month for 10 months were excluded.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
ThereasaCronan, Principal Investigator, San Diego State University
San Diego State University
San Diego, California, 92120
United States
Additional Information:
Study ID Numbers: NIAMS-029; R01 AR44020
Study Start Date: September 1996
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000423
Other Quality Of Life Studies:
1. Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
2. Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
3. Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases
4. Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
5. Chemotherapy Decisions and Outcomes in Older Women With Newly Diagnosed Breast Cancer
Related Studies:
Other Quality of Life Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Support, Health, and Fibromyalgia
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