Trial record 21 of 107 for:    fibromyalgia | Open Studies | Interventional Studies

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

June 22, 2012
April 22, 2013
January 2012
October 2013   (final data collection date for primary outcome measure)
scores on Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01628822 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Fibromyalgia
  • 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
  • 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
  • Experimental: Active relaxation
    Intervention: Behavioral: Active relaxation
  • Placebo Comparator: Placebo relaxation
    Intervention: Behavioral: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: SERRA Eric, Dr 00333-22-66-88-20 Serra.eric@chu-amiens.fr
France
 
NCT01628822
AOL11-Dr SERRA, 2011-A01055-36
No
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
Not Provided
Principal Investigator: SERRA Eric, Dr Activity Centre "Pain", University Hospital of Amiens
Centre Hospitalier Universitaire, Amiens
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP