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Fibromyalgia Therapeutic Education in Thermal Cure (FiETT)

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ClinicalTrials.gov Identifier: NCT02406313
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

March 25, 2015
April 2, 2015
November 14, 2018
March 2015
September 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02406313 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
  • 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)
  • Pain relief [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in pain relief measured on a VAS
  • Kinesiophobia index [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in kinesiophobia measured by TAMPA scale
  • Catastrophizing index [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)
  • 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
  • Fatigue [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in fatigue measured by Picot scale
  • Somnolence [ Time Frame: Week 03, Month 03, Month 06, Month 12 ]
    Average change from baseline in somnolence measured by Epworth scale
  • 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
  • Serious adverse reactions (SARs) [ Time Frame: Day 00 to Month 12 ]
    Probability of occurrence of SARs
  • drug consumption [ Time Frame: Day 00, Week 03, Month 03, Month 06, Month 12 ]
    change in drug consumption
  • non-drug treatment consumption [ Time Frame: Day 00, Week 03, Month 03, Month 06, Month 12 ]
    change in non-drug treatment consumption
  • Thermal outbreaks [ Time Frame: Day 00 to Week 03 ]
    Probability of occurrence of thermal outbreaks during the cure period
  • Fibromyalgia outbreaks [ Time Frame: Week 03 to Month 12 ]
    Probability of occurrence fibromyalgia outbreaks during remote follow-up
Same as current
Not Provided
Not Provided
 
Fibromyalgia Therapeutic Education in Thermal Cure
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
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Fibromyalgia
  • Other: CTS
    Standardized Thermal Cure
  • Other: ETP
    Patient Therapeutic Education
  • 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.
    Interventions:
    • Other: CTS
    • Other: ETP
  • 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.
    Intervention: Other: CTS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
152
Same as current
December 31, 2018
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02406313
2014-A00464-43
No
Not Provided
Plan to Share IPD: No
Association Francaise pour la Recherche Thermale
Association Francaise pour la Recherche Thermale
Not Provided
Principal Investigator: Philippe DUCAMP, MD Centre de Médecine et de Traumatologie du Sport
Association Francaise pour la Recherche Thermale
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP