Fibromyalgia Therapeutic Education in Thermal Cure
- Conditions
- Fibromyalgia
- Interventions
- Other: CTSOther: ETP
- Registration Number
- NCT02406313
- Lead Sponsor
- Association Francaise pour la Recherche Thermale
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 152
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CTS + ETP ETP Patients following a standardized thermal cure (CTS) follow an additional program called Fibr'eaux (ETP) that consists in discussion groups and physical activities allowing patients to learn how to manage their illness. CTS + ETP CTS Patients following a standardized thermal cure (CTS) follow an additional program called Fibr'eaux (ETP) that consists in discussion groups and physical activities allowing patients to learn how to manage their illness. CTS alone CTS Patients follow a standardized thermal cure that is a sedative, relaxing, antalgic and mobilizing treatment based on muds application, hydrotherapy and physiotherapy. The cure is made of 72 treatments selected among a list including muds application, massages, reeducation in thermal pool, baths and showers.
- Primary Outcome Measures
Name Time Method Change in quality of life 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 Outcome Measures
Name Time Method drug consumption Day 00, Week 03, Month 03, Month 06, Month 12 change in drug consumption
Thermal outbreaks Day 00 to Week 03 Probability of occurrence of thermal outbreaks during the cure period
non-drug treatment consumption Day 00, Week 03, Month 03, Month 06, Month 12 change in non-drug treatment consumption
Pain intensity Week 03, Month 03, Month 06, Month 12 Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)
Somnolence Week 03, Month 03, Month 06, Month 12 Average change from baseline in somnolence measured by Epworth scale
Serious adverse reactions (SARs) Day 00 to Month 12 Probability of occurrence of SARs
Function impairment Week 03, Month 03, Month 06, Month 12 Average change from baseline in function impairment measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) scale
Responder rate Week 03, Month 03, Month 06, Month 12 Rate of patients responding to intervention, i.e. with FIQ score increased from at least 14% as compared to Day 00
Anxiety and depression Week 03, Month 03, Month 06, Month 12 Average change from baseline in anxiety and depression measured by Hospital Anxiety and Average change from baseline in anxiety and depression measured by Hospital ANxiety and Depression scale
Kinesiophobia index Week 03, Month 03, Month 06, Month 12 Average change from baseline in kinesiophobia measured by TAMPA scale
Change in quality of life Week 03, Month 03, Month 12 Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)
Pain relief Week 03, Month 03, Month 06, Month 12 Average change from baseline in pain relief measured on a VAS
Catastrophizing index Week 03, Month 03, Month 06, Month 12 Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)
Fatigue Week 03, Month 03, Month 06, Month 12 Average change from baseline in fatigue measured by Picot scale
Fibromyalgia outbreaks Week 03 to Month 12 Probability of occurrence fibromyalgia outbreaks during remote follow-up
Trial Locations
- Locations (1)
OTD
🇫🇷Dax, Aquitaine, France