Fibromyalgia Clinical Trial
— Sophrodol-1Official title:
Pilot Study, Prospective, Single Center,Randomized, Single Blind, Evaluating the Efficacy of Relaxation to 12 Weeks Against Placebo, in the Overall Care Chronic Pain in Patients With Fibromyalgia
The main objective of this protocol is to measure the improvement of the overall situation
of patients with diffuse chronic pain or fibromyalgia to 12 weeks by non-drug treatment
relaxation.
Secondarily,is to evaluate the evolution of physical variables, psychological and social
improvement of the quality of life. To evaluate the evolution of drug consumption
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men or women over 18 years - established diagnosis of fibromyalgia as defined by the American College of Rheumatology: widespread pain and eleven tender points at 18 sites listed (ACR, 1990) - EVA = 4 (on a scale of 10 cm) - no change in treatment for 15 days, except for treatment "on demand" or "rescue" - patient has given its written consent - patient wishing to benefit from relaxation sessions - people who can meet the self-assessment and hetero-assessment - people with a social security number Exclusion Criteria: - any painful situation that cannot be distinguished from fibromyalgia pain by the patient - patients untreated or treated for less than a month - patient with psychosis or severe depression or severe anxiety or impulsivity characterized, at the discretion of the clinician. - patients receiving benzodiazepines at the request - patient with deafness - patient after a body treatment using a relaxation method, relaxation therapy or hypnosis |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Activity Centre "Pain" | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | scores on Fibromyalgia Impact Questionnaire (FIQ) | 12 weeks | No |
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