Fibromyalgia Clinical Trial
Official title:
Assessment of Art Therapy Program for Women With Fibromyalgia: Randomized, Controlled, Blinded Study
Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Classification of fibromyalgia by ACR criteria (Wolf et al, 1990) - Females - Without distinction of race - Age 18 to 65 years - Do not have changed treatment for fibromyalgia for at least 3meses - signing the consent form Exclusion Criteria: - Other ostearticulares rheumatic and painful - Decompensated cardio-respiratory diseases - Perform physical activity more than 2x a week for more than 3 months |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Andréia Salvador Baptista | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pain | Evaluated with the visual analogue scale | baseline, after 10 weeks, 20 weeks and 40 weeks | No |
Secondary | Change in fibromyalgia impact | Evaluated using the Fibromyalgia Impact Questionnaire | Baseline, after 10, 20 and 40 weeks | No |
Secondary | Change in Quality of life | Evaluated using the SF-36 questionnaire | Baseline, after 10, 20 and 40 weeks | No |
Secondary | Change in Body image | Evaluated using the Body Dismorphic Disorder Examination (BDDE) questionnaire | Basline, after 10, 20 and 40 weeks | No |
Secondary | Change in Functional capacity | Evaluated using the six minute walk test | Baseline, after 10, 20 and 40 weeks | No |
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