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Fibromyalgia Therapeutic Education in Thermal Cure (FiETT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02406313
Recruitment Status : Unknown
Verified June 2018 by Association Francaise pour la Recherche Thermale.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: CTS Other: ETP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients
Study Start Date : March 2015
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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

Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: Month 06 after cure completion ]
    Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion.

Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: Week 03, Month 03, Month 12 ]
    Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)

  2. Responder rate [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Rate of patients responding to intervention, i.e. with FIQ score increased from at least 14% as compared to Day 00

  3. Pain intensity [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in pain intensity measured on a Visual Analogical Scale (VAS)

  4. Pain relief [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in pain relief measured on a VAS

  5. Kinesiophobia index [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in kinesiophobia measured by TAMPA scale

  6. Catastrophizing index [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)

  7. Function impairment [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in function impairment measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) scale

  8. Fatigue [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in fatigue measured by Picot scale

  9. Somnolence [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in somnolence measured by Epworth scale

  10. Anxiety and depression [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    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

  11. Serious adverse reactions (SARs) [ Time Frame: Day 00 to Month 12 ]
    Probability of occurrence of SARs

  12. drug consumption [ Time Frame: Day 00, Week 03, Month 03, Month 06, Month 12 ]
    change in drug consumption

  13. non-drug treatment consumption [ Time Frame: Day 00, Week 03, Month 03, Month 06, Month 12 ]
    change in non-drug treatment consumption

  14. Thermal outbreaks [ Time Frame: Day 00 to Week 03 ]
    Probability of occurrence of thermal outbreaks during the cure period

  15. Fibromyalgia outbreaks [ Time Frame: Week 03 to Month 12 ]
    Probability of occurrence fibromyalgia outbreaks during remote follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02406313

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Dax, Aquitaine, France, 40180
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
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Principal Investigator: Philippe DUCAMP, MD Centre de Médecine et de Traumatologie du Sport
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Responsible Party: Association Francaise pour la Recherche Thermale Identifier: NCT02406313    
Other Study ID Numbers: 2014-A00464-43
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases