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Trial record 22 of 97 for:    fibromyalgia | Open Studies | Interventional Studies

Fibromyalgia Therapeutic Education in Thermal Cure (FiETT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Association Francaise pour la Recherche Thermale
Sponsor:
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier:
NCT02406313
First received: March 25, 2015
Last updated: January 27, 2016
Last verified: December 2015
  Purpose
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 Intervention
Fibromyalgia
Other: CTS
Other: ETP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients

Resource links provided by NLM:


Further study details as provided by Association Francaise pour la Recherche Thermale:

Primary Outcome Measures:
  • Change in quality of life [ Time Frame: Month 06 after cure completion ] [ Designated as safety issue: No ]
    Change from baseline in quality of life assessed through the self-administered Fibromyalgia Impact Questionnaire (FIQ) month 06 after cure completion.


Secondary Outcome Measures:
  • Change in quality of life [ Time Frame: Week 03, Month 03, Month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Average change from baseline in pain relief measured on a VAS

  • Kinesiophobia index [ Time Frame: Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    Average change from baseline in kinesiophobia measured by TAMPA scale

  • Catastrophizing index [ Time Frame: Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    Average change from baseline in catastrophizing measured by pain catastrophizing scale (PCS)

  • Function impairment [ Time Frame: Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Average change from baseline in fatigue measured by Picot scale

  • Somnolence [ Time Frame: Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    Average change from baseline in somnolence measured by Epworth scale

  • Anxiety and depression [ Time Frame: Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Probability of occurrence of SARs

  • drug consumption [ Time Frame: Day 00, Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    change in drug consumption

  • non-drug treatment consumption [ Time Frame: Day 00, Week 03, Month 03, Month 06, Month 12 ] [ Designated as safety issue: No ]
    change in non-drug treatment consumption

  • Thermal outbreaks [ Time Frame: Day 00 to Week 03 ] [ Designated as safety issue: Yes ]
    Probability of occurrence of thermal outbreaks during the cure period

  • Fibromyalgia outbreaks [ Time Frame: Week 03 to Month 12 ] [ Designated as safety issue: Yes ]
    Probability of occurrence fibromyalgia outbreaks during remote follow-up


Estimated Enrollment: 152
Study Start Date: March 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02406313

Contacts
Contact: Hermine WAFFO TEGUO, MSc +33 (0)7 85 87 28 64 hermine.gayum-waffo-teguo@isped.u-bordeaux2.fr
Contact: Valérie JOURNOT, PhD +33 (0)5 57 57 92 45 valerie.journot@inserm.fr

Locations
France
OTD Recruiting
Dax, Aquitaine, France, 40180
Contact: Maguy BLANC    +33 (0)5 58 56 68 55      
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Investigators
Principal Investigator: Philippe DUCAMP, MD Centre de Médecine et de Traumatologie du Sport
  More Information

Publications:
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Marchand S. Influences des hormones sexuelles sur les mécanismes endogens impliqués dans le développement et la persistance de la douleur. Congrès SFETD, Nantes, 2006, Douleurs, nov.2006, CS04
Houvenagel E. Physiopathologie de la douleur de la fibromyalgie. Rev.Rhum.70(2003) :314-320
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Mailhan L. (2005). Qualité de vie après traumatisme crânien sévère. Pratiques psychologiques, 11, 343-357
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Coichard CG, Cabane J et al.Intérêt d'une prise en charge multidisciplinaire du patient fibromyalgique. Rev.Rhum. (2003) ; 70 :354-7
Miadsi D, Juniper MD. et al. The pharmacological management of fibromyalgia syndrome in the UK primary care setting. Eular, 2008, Paris. OP0076
Trèves R, Bannwarth B, Bertin P, Javier RM, Glowinski J, Le Bars M, Perrot S. Les Recommandations de Limoges. Usage de la morphine dans les douleurs rhumatismales non cancéreuses. Douleurs, 2000, 1,1, 33-38
Arnold L, Goldenberg D, Clauw DJ, Palmer RH, Mease P, Gendreau RM. One-year durability of response to Milnacipran treatment for fibromyalgia. Eular 2008, Paris, THU0359
Branco JC, Perrot S, Bragee G, Zachrisson O, Mikkelsen K, Mainguy Y, Pezous N. Milnacipran for the treatment of fibromyalgia syndrome : a European multicenter, randomized, double-blind, placebo-controlled trial. Eular 2008, Paris, THU0365
Zijlstra TR, Barendregt PJ, van De Laar MA. Venlafaxine in fibromyalgia: results of a randomized placebo-controlled, double-blind trial. Arthritis Rheum. 2002;46:S105
Clère F, Henry F, Perriot M. Quelle place pour le clonazepam dans la douleur chronique ? Douleurs, vol7n°6 dec 2006 :314-317
Barrett J, Russell J, Pauer L, Whalen E, Leon T, Zeiher B. The effect of pregabalin treatment on changes in pain and sleep quality in fibromyalgia patients.Eular 2008, Paris, THU0362
Arkfeld DG, Setoodeh KM, Abrahim J, Cole SE, Metyas S. The inability of most us patients to tolerate the recommended doses of pregabalin in the treatment of fibromyalgia ;: a case study. Elar 2008, Paris, THU0396
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Journal Officiel de la République Française, 9 août 2006. Arrêté du 1er août 2006 portant approbation d'un avenant à la convention nationale thermale.
Thermalisme et santé publique vers de nouvelles convergences. Livre Blanc CNETH 2008.
Rapport 2011 du Conseil National du Tourisme pour le Ministre chargé du Tourisme " réflexions et propositions sur la diversification des stationsThermales ".
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Simon D, Traynard PY, Bourdillon F, Gagnaire R, Grimaldi A. Education thérapeutique, prévention et maladies chroniques. Masson. 2ème édition 2011.
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Ducamp Ph.Le thermalisme peut-il être le lieu idéal de la prise en charge des patients fibromyalgiques ? Mémoire de fin d'études du diplôme universitaire d'éducation thérapeutique de formation et de coordination d'équipe. UMFMC Université Bordeaux Segalen 2012.
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Grille OPTIMON évaluant le risque patient dans les études de recherche clinique institutionnelles
Sous-groupe de travail Qualité de la promotion - Plan de monitoring adapté - DRCI Hospices Civils de Lyon. Elaboration du plan de monitoring adapté pour une recherche biomédicale à promotion institutionnelle

Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT02406313     History of Changes
Other Study ID Numbers: 2014-A00464-43 
Study First Received: March 25, 2015
Last Updated: January 27, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 06, 2016