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

Centre Hospitalier Universitaire, Amiens1 site in 1 country80 target enrollmentJanuary 1, 2012

ConditionsFibromyalgia

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Centre Hospitalier Universitaire, Amiens
Enrollment: 80
Locations: 1
Primary Endpoint: scores on Fibromyalgia Impact Questionnaire (FIQ)
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 1, 2012

End Date

October 1, 2014

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire, Amiens

Responsible Party

Sponsor

Eligibility Criteria

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