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

NCT ID: NCT01628822

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-10-31

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

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active relaxation

Group Type: EXPERIMENTAL

Active relaxation

Intervention Type: 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 relaxation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

Active relaxation

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

Intervention Type: BEHAVIORAL

Placebo

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SERRA Eric, Dr

Role: PRINCIPAL_INVESTIGATOR

Activity Centre "Pain", University Hospital of Amiens

Locations

Activity Centre "Pain"

Amiens, , France

Countries

France

References

Douleur analg. (2023) 36:73-82 DOI 10.3166/dea-2022-0249, Efficacité de la relaxation dans la fibromyalgie : un essai clinique bref aléatoirement contrôlé en simple insu portant sur 80 patients

Reference Type: RESULT

Other Identifiers

2011-A01055-36

Identifier Type: OTHER

Identifier Source: secondary_id

AOL11-DR-SERRA

Identifier Type: -

Identifier Source: org_study_id