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

CompletedPhase 3NCT01628822
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official 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
Conditions
Interventions
  • Behavioral: Active relaxation
  • Behavioral: Placebo
Sponsor
Centre Hospitalier Universitaire, Amiens
Start date
2012-01
Primary completion
2014-10
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01628822