Efficacy Study 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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Activity Centre "Pain"

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active relaxation

Behavioral

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

Placebo

Behavioral

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

Primary outcomes

scores on Fibromyalgia Impact Questionnaire (FIQ)

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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

Acronym: Sophrodol-1

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 27, 2012
Registry last updated: Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed