Fibromyalgia Therapeutic Education in Thermal Cure (FiETT)

Association Francaise pour la Recherche Thermale

Status: Unknown

Conditions: Fibromyalgia

Treatments: Other: ETP; Other: CTS

Study type: Interventional

Funder types: Other

Identifiers

NCT02406313

2014-A00464-43

Details and patient eligibility

About

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

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

CTS + ETP

Experimental group

Description:

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.

Treatment:

Other: ETP

Other: CTS

CTS alone

Active Comparator group

Description:

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.

Treatment:

Other: CTS