Fibromyalgia Therapeutic Education in Thermal Cure

NCT ID: NCT02406313

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CTS + ETP

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.

Group Type: EXPERIMENTAL

CTS

Intervention Type: OTHER

Standardized Thermal Cure

ETP

Intervention Type: OTHER

Patient Therapeutic Education

CTS alone

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.

Group Type: ACTIVE_COMPARATOR

CTS

Intervention Type: OTHER

Standardized Thermal Cure

Interventions

CTS

Standardized Thermal Cure

Intervention Type: OTHER

ETP

Patient Therapeutic Education

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DUCAMP, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Médecine et de Traumatologie du Sport

Locations

OTD

Dax, Aquitaine, France

Countries

France

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PMID: 19369473 (View on PubMed)

Other Identifiers

2014-A00464-43

Identifier Type: -

Identifier Source: org_study_id