Text Size

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

This study is currently recruiting participants.
Verified April 2013 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01628822
First received: June 22, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Fibromyalgia
 Behavioral: Active relaxation
Behavioral: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • scores on Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628822

Contacts
Contact: SERRA Eric, Dr 00333-22-66-88-20 Serra.eric@chu-amiens.fr

Locations
France
Activity Centre "Pain" Recruiting
Amiens, France, 80054
Contact: SERRA Eric, Dr     0333-22-66-88-20     Serra.eric@chu-amiens.fr    
Principal Investigator: SERRA Eric, Dr            
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: SERRA Eric, Dr Activity Centre "Pain", University Hospital of Amiens
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01628822     History of Changes
Other Study ID Numbers: AOL11-Dr SERRA, 2011-A01055-36
Study First Received: June 22, 2012
Last Updated: April 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013