- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628822
Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)
April 27, 2016 updated by: Centre Hospitalier Universitaire, Amiens
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amiens, France, 80054
- Activity Centre "Pain"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active relaxation
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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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
scores on Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 12 weeks
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SERRA Eric, Dr, Activity Centre "Pain", University Hospital of Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
June 22, 2012
First Submitted That Met QC Criteria
June 26, 2012
First Posted (Estimate)
June 27, 2012
Study Record Updates
Last Update Posted (Estimate)
April 28, 2016
Last Update Submitted That Met QC Criteria
April 27, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOL11-DR-SERRA
- 2011-A01055-36 (Other Identifier: ID-RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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