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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT01628822

First received: June 22, 2012

Last updated: April 27, 2016

Last verified: April 2016

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:

MedlinePlus related topics: Chronic Pain Fibromyalgia

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 ]


Enrollment:	80
Study Start Date:	January 2012
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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 27, 2016
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:


Chronic Pain Fibromyalgia Myofascial Pain Syndromes Pain Neurologic Manifestations Nervous System Diseases	Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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