Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Association Francaise pour la Recherche Thermale
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Change in quality of life
- Last Updated
- 7 years ago
Overview
Brief Summary
The study evaluates the efficiency, in terms of quality of life improvement, of a patient's therapeutic education program (ETP), based on long term commitment in adapted physical activities carried out during a standardized thermal cure (CTS) for fibromyalgia among patients continuing regular drug treatment or not
Detailed Description
Fibromyalgia is a poorly known and understood disease. Patients suffer from pain, fatigue, sleep disorders, anxiety, depression, preventing them from moving and going out, resulting in an alteration of social life. Multiple drugs treatment is frequently used but is burdensome and poorly effective. However, thermal cure proved efficacious to improve quality of life during the cure and beyond. This study aims at demonstrating the added value of a patient's therapeutic education program provided during a thermal cure, a moment where patients are available and receptive to guidance.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in quality of life
Time Frame: Month 06 after cure completion
Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion.
Secondary Outcomes
- Pain intensity(Week 03, Month 03, Month 06, Month 12)
- Function impairment(Week 03, Month 03, Month 06, Month 12)
- Responder rate(Week 03, Month 03, Month 06, Month 12)
- Somnolence(Week 03, Month 03, Month 06, Month 12)
- Serious adverse reactions (SARs)(Day 00 to Month 12)
- non-drug treatment consumption(Day 00, Week 03, Month 03, Month 06, Month 12)
- Kinesiophobia index(Week 03, Month 03, Month 06, Month 12)
- Anxiety and depression(Week 03, Month 03, Month 06, Month 12)
- drug consumption(Day 00, Week 03, Month 03, Month 06, Month 12)
- Thermal outbreaks(Day 00 to Week 03)
- Change in quality of life(Week 03, Month 03, Month 12)
- Pain relief(Week 03, Month 03, Month 06, Month 12)
- Catastrophizing index(Week 03, Month 03, Month 06, Month 12)
- Fatigue(Week 03, Month 03, Month 06, Month 12)
- Fibromyalgia outbreaks(Week 03 to Month 12)