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

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Active relaxation; Behavioral: Placebo

• Registration Number: NCT01628822
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active relaxation	Active relaxation	-
Placebo relaxation	Placebo	-

Primary Outcome Measures

Name	Time	Method
scores on Fibromyalgia Impact Questionnaire (FIQ)	12 weeks

Trial Locations

Locations (1)

Activity Centre "Pain"; 🇫🇷 Amiens, France