Fibromyalgia Therapeutic Education in Thermal Cure (FiETT)

Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients

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

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: CTS; Other: ETP

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Dax, Aquitaine, France, 40180
      • OTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: CTS; Standardized Thermal Cure; Other: ETP; Patient Therapeutic Education
Active Comparator: 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.	Other: CTS; Standardized Thermal Cure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Association Francaise pour la Recherche Thermale
• Investigators: Principal Investigator: Philippe DUCAMP, MD, Centre de Médecine et de Traumatologie du Sport

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2014-A00464-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO