Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)

Centre Hospitalier Universitaire, Amiens

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Behavioral: Active relaxation

Behavioral: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01628822

2011-A01055-36 (Other Identifier)

AOL11-DR-SERRA

Details and patient eligibility

About

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

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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