Back to resultsEfficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia (Sophrodol-1)
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Active relaxation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Relaxation, Improving the quality of life
Eligibility Criteria
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
Sites / Locations
- Activity Centre "Pain"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active relaxation
Placebo relaxation
Arm Description
Outcomes
Primary Outcome Measures
scores on Fibromyalgia Impact Questionnaire (FIQ)
Secondary Outcome Measures
Full Information
NCT ID
NCT01628822
First Posted
June 22, 2012
Last Updated
April 27, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT01628822
Brief Title
Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia
Acronym
Sophrodol-1
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 Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Relaxation, Improving the quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active relaxation
Arm Type
Experimental
Arm Title
Placebo relaxation
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Active relaxation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
scores on Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SERRA Eric, Dr
Organizational Affiliation
Activity Centre "Pain", University Hospital of Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Activity Centre "Pain"
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia
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