Fibromyalgia Clinical Trial
Official title:
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment
The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.
Status | Completed |
Enrollment | 153 |
Est. completion date | February 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology - being 18 years or older and - having had continuous chronic pain for at least 6 months. Exclusion Criteria: - Patients were excluded if they did not agree to participate in the study, - were suffering from a severe psychiatric or organic disorder, or - were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Galdakao-Usansolo | Galdakao | Bizkaia |
Lead Sponsor | Collaborator |
---|---|
Hospital Galdakao-Usansolo |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) | Fibromyalgia patients completed the FIQ at baseline and again 6 months after the interdisciplinary intervention. | 6 months | No |
Secondary | Anxiety and depressive symptoms (HADS: The Hospital Anxiety and Depression Scale) | Patients with fibromyalgia completed the HADS at baseline and again 6 months after the intervention | 6 months | No |
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