Fibromyalgia Therapeutic Education in Thermal Cure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: CTS
* Other: ETP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTS + ETP<br>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. | Other: CTS<br>* Standardized Thermal Cure<br>Other: ETP<br>* Patient Therapeutic Education<br>|
| Active Comparator: CTS alone<br>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. | Other: CTS<br>* Standardized Thermal Cure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion. | Month 06 after cure completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS) | Week 03, Month 03, Month 12 | 
| Responder rate | Rate of patients responding to intervention, i.e. with FIQ score increased from at least 14% as compared to Day 00 | Week 03, Month 03, Month 06, Month 12 | 
| Pain intensity | Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS) | Week 03, Month 03, Month 06, Month 12 | 
| Pain relief | Average change from baseline in pain relief measured on a VAS | Week 03, Month 03, Month 06, Month 12 | 
| Kinesiophobia index | Average change from baseline in kinesiophobia measured by TAMPA scale | Week 03, Month 03, Month 06, Month 12 | 
| Catastrophizing index | Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS) | Week 03, Month 03, Month 06, Month 12 | 
| Function impairment | Average change from baseline in function impairment measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) scale | Week 03, Month 03, Month 06, Month 12 | 
| Fatigue | Average change from baseline in fatigue measured by Picot scale | Week 03, Month 03, Month 06, Month 12 | 
| Somnolence | Average change from baseline in somnolence measured by Epworth scale | Week 03, Month 03, Month 06, Month 12 | 
| Anxiety and depression | 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 | Week 03, Month 03, Month 06, Month 12 | 
| Serious adverse reactions (SARs) | Probability of occurrence of SARs | Day 00 to Month 12 | 
| drug consumption | change in drug consumption | Day 00, Week 03, Month 03, Month 06, Month 12 | 
| non-drug treatment consumption | change in non-drug treatment consumption | Day 00, Week 03, Month 03, Month 06, Month 12 | 
| Thermal outbreaks | Probability of occurrence of thermal outbreaks during the cure period | Day 00 to Week 03 | 
| Fibromyalgia outbreaks | Probability of occurrence fibromyalgia outbreaks during remote follow-up | Week 03 to Month 12 |