Efficacy Study of Relaxation to 12 Weeks Against Placebo in the Overall Care Chronic Pain in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628822
• Other study ID #: AOL11-DR-SERRA
• Secondary ID: 2011-A01055-36
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2012
• Last updated: April 27, 2016
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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
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

Locations

Country	Name	City	State
France	Activity Centre "Pain"	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scores on Fibromyalgia Impact Questionnaire (FIQ)		12 weeks	No