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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)

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ClinicalTrials.gov Identifier: NCT01628822
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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


Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Active relaxation Behavioral: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


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