Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Active relaxation
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active relaxation<br> | Behavioral: Active relaxation<br>* The length of follow-up will be 12 weeks.Patients will be seen once every seven days by a relaxation therapist for 5 weeks (6 sessions) and will be followed by the center physician investigator regarding drug therapy<br>|
| Placebo Comparator: Placebo relaxation<br> | Behavioral: Placebo<br>* Patients are been asked to relax alone in a quiet room. They are coming every 7 days for 5 weeks (6 sessions) and will be followed by the investigator regarding drug therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scores on Fibromyalgia Impact Questionnaire (FIQ) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Relaxation, Improving the quality of life