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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTS + ETP | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTS | Other | Standardized Thermal Cure |
| |
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Philippe DUCAMP, MD | Centre de Médecine et de Traumatologie du Sport | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OTD | Dax | Aquitaine | 40180 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16777329 | Background | Diatchenko L, Nackley AG, Slade GD, Fillingim RB, Maixner W. Idiopathic pain disorders--pathways of vulnerability. Pain. 2006 Aug;123(3):226-230. doi: 10.1016/j.pain.2006.04.015. Epub 2006 Jun 13. No abstract available. | |
| Background | Branco JC, Saraiva F et al. Fibromyalgia Syndrom : A european epidemiological survey. Abstract Sat 0452 Eular 2005 | ||
| 7818567 |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ETP |
| Other |
Patient Therapeutic Education |
|
| 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 |
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| Background | Nguyen Ba B, Dubourg K, Pécastaings S, Optimisation de la lutte contre les légionnelles et autres opportunistes dans les réseaux d'eau minérale naturelle, grâce à un pilote "eau thermale". Press Therm Clim 2006;143:7-123 |
| Background | R Forestier, A Françon, Graber-Duvernay B, Palmer M, sevez JF, Guillemot A, BErnard JP, Souchon JF, Gerrud S, Le Provost C, Joly J, Rogeaux O, Deschamps O. Incidence des événements infectieux survenus en cure thermale dans une population de curistes présu- més vulnérables : étude contrôlée longitudinale sur 738 patients. Press Therm Clim 2008;145:9-21 |
| Background | Dubourg K, Grégoire P, Lagière J. La désinfection des piscines thermales de Dax. Press Therm Clim 2008;145:61-71 |
| Background | Ducamp P. Fibromyalgie et thermalisme. 10ème Congrès National de la Fibromyalgie FNAFF. Nîmes, 13 octobre 2012. |
| Background | Grille OPTIMON évaluant le risque patient dans les études de recherche clinique institutionnelles |
| Background | Sous-groupe de travail Qualité de la promotion - Plan de monitoring adapté - DRCI Hospices Civils de Lyon. Elaboration du plan de monitoring adapté pour une recherche biomédicale à promotion institutionnelle |
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| D009422 |
| Nervous System Diseases |