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

NCT01628822 | Completed Phase 3

• 2 other identifiers: AOL11-DR-SERRA2011-A01055-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Fibromyalgia; Relaxation; Improving the quality of life

Outcome Measures

Primary Outcomes (1)

• scores on Fibromyalgia Impact Questionnaire (FIQ)

  12 weeks

Study Arms (2)

Active relaxation

EXPERIMENTAL

Behavioral: Active relaxation

Placebo relaxation

PLACEBO COMPARATOR

Behavioral: Placebo

Interventions

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

Active relaxation

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

Placebo relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Activity Centre "Pain"

Amiens, 80054, France

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• SERRA Eric, Dr

  Activity Centre "Pain", University Hospital of Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 27, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (1)