Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)
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ClinicalTrials.gov Identifier: NCT01628822 |
Recruitment Status :
Completed
First Posted : June 27, 2012
Last Update Posted : April 28, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Behavioral: Active relaxation Behavioral: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- scores on Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628822
France | |
Activity Centre "Pain" | |
Amiens, France, 80054 |
Principal Investigator: | SERRA Eric, Dr | Activity Centre "Pain", University Hospital of Amiens |
Responsible Party: | Centre Hospitalier Universitaire, Amiens |
ClinicalTrials.gov Identifier: | NCT01628822 History of Changes |
Other Study ID Numbers: |
AOL11-DR-SERRA 2011-A01055-36 ( Other Identifier: ID-RCB ) |
First Posted: | June 27, 2012 Key Record Dates |
Last Update Posted: | April 28, 2016 |
Last Verified: | April 2016 |
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Fibromyalgia Relaxation Improving the quality of life |
Additional relevant MeSH terms:
Chronic Pain Fibromyalgia Myofascial Pain Syndromes Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases |