Fibromyalgia Therapeutic Education in Thermal Cure
FiETT
Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients
1 other identifier
interventional
152
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedNovember 14, 2018
June 1, 2018
2.5 years
March 25, 2015
November 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Change in quality of life
Week 03, Month 03, Month 12
Responder rate
Week 03, Month 03, Month 06, Month 12
Pain intensity
Week 03, Month 03, Month 06, Month 12
Pain relief
Week 03, Month 03, Month 06, Month 12
Kinesiophobia index
Week 03, Month 03, Month 06, Month 12
- +10 more secondary outcomes
Study Arms (2)
CTS + ETP
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OTD
Dax, Aquitaine, 40180, France
Related Publications (108)
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PMID: 19369473BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe DUCAMP, MD
Centre de Médecine et de Traumatologie du Sport
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
April 2, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2017
Study Completion
December 31, 2018
Last Updated
November 14, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share