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

This study has been completed.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens Identifier:
First received: June 22, 2012
Last updated: April 27, 2016
Last verified: April 2016

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

Condition Intervention Phase
Behavioral: Active relaxation
Behavioral: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • scores on Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 12 weeks ]

Enrollment: 80
Study Start Date: January 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active relaxation Behavioral: 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
Placebo Comparator: Placebo relaxation 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01628822

Activity Centre "Pain"
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Principal Investigator: SERRA Eric, Dr Activity Centre "Pain", University Hospital of Amiens
  More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT01628822     History of Changes
Other Study ID Numbers: AOL11-DR-SERRA
2011-A01055-36 ( Other Identifier: ID-RCB )
Study First Received: June 22, 2012
Last Updated: April 27, 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Improving the quality of life

Additional relevant MeSH terms:
Chronic Pain
Myofascial Pain Syndromes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases processed this record on May 25, 2017