Fibromyalgia
Conditions
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.
Interventions
OTHERCTS
Standardized Thermal Cure
OTHERETP
Patient Therapeutic Education
Sponsors
Association Francaise pour la Recherche Thermale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnostic of fibromyalgia done at least 6 months before thermal cure * Diagnostic of fibromyalgia confirmed by FIRST questionnaire (score 5) during the initial thermal checkup * Age between 18 and 65 years * Access to an Internet connection during remote follow-up * Affiliation to a social security system (recipient or assignee) * Signed written inform consent form
Exclusion criteria
* Infectious diseases with ongoing treatment (except for winter upper respiratory tract pathologies) * Active tumorous pathology * Concomitant inflammatory rheumatism * Stage III chronic venous insufficiency with history of phlebitis and/or pulmonary embolism * Incapacity to receive treatment in hot water ( ≥36°) * Total incapacity to practice physical activities of therapeutic education program * Ongoing pregnancy * Involvement in a structured educational program specific to fibromyalgia during the previous year * Incapacity to understand French language making the follow up impossible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain intensity | Week 03, Month 03, Month 06, 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 |
| Kinesiophobia index | Week 03, Month 03, Month 06, Month 12 | Average change from baseline in kinesiophobia measured by TAMPA scale |
| Catastrophizing index | Week 03, Month 03, Month 06, Month 12 | Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS) |
| 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 |
| Fatigue | Week 03, Month 03, Month 06, Month 12 | Average change from baseline in fatigue measured by Picot 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) |
| 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 |
| Serious adverse reactions (SARs) | Day 00 to Month 12 | Probability of occurrence of SARs |
| drug consumption | Day 00, Week 03, Month 03, Month 06, Month 12 | change in drug consumption |
| non-drug treatment consumption | Day 00, Week 03, Month 03, Month 06, Month 12 | change in non-drug treatment consumption |
| Thermal outbreaks | Day 00 to Week 03 | Probability of occurrence of thermal outbreaks during the cure period |
| Fibromyalgia outbreaks | Week 03 to Month 12 | Probability of occurrence fibromyalgia outbreaks during remote follow-up |
| Somnolence | Week 03, Month 03, Month 06, Month 12 | Average change from baseline in somnolence measured by Epworth scale |
Countries
France
Outcome results
None listed