Fibromyalgia Therapeutic Education in Thermal Cure

Association Francaise pour la Recherche Thermale152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

152

Conditions

Fibromyalgia

Interventions

CTSOTHER

Standardized Thermal Cure

ETPOTHER

Patient Therapeutic Education

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

OTD

Dax, Aquitaine, France

Outcomes

Primary Outcomes

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.

Time frame: Month 06 after cure completion

Secondary Outcomes

Change in quality of life

Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)

Time frame: 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