NCT02406313

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 14, 2018

Status Verified

June 1, 2018

Enrollment Period

2.5 years

First QC Date

March 25, 2015

Last Update Submit

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

EXPERIMENTAL

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: CTSOther: ETP

CTS alone

ACTIVE COMPARATOR

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

Interventions

CTSOTHER

Standardized Thermal Cure

CTS + ETPCTS alone
ETPOTHER

Patient Therapeutic Education

CTS + ETP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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  • Graber-Duvernay B. Pseudomonas aeruginosa et infections broncho-pulmonaires. Presse Therm Clim 2002; 139: 35-40

    BACKGROUND
  • Morin J.P, Graber-Duvernay B. Surveillance des pseudomonas et expériences de désinfection. Presse Therm Clim 2002; 139: 41-51

    BACKGROUND
  • Hartemann Ph. Quelles mesures préconiser pour une gestion raisonnée du risque dû a Pseudomonas aeruginosa ? Presse therm climat 2002; 139: 53-57

    BACKGROUND
  • Nguyen Ba B, Dubourg K, Pécastaings S, Optimisation de la lutte contre les légionnelles et autres opportunistes dans les réseaux d'eau minérale naturelle, grâce à un pilote "eau thermale". Press Therm Clim 2006;143:7-123

    BACKGROUND
  • R Forestier, A Françon, Graber-Duvernay B, Palmer M, sevez JF, Guillemot A, BErnard JP, Souchon JF, Gerrud S, Le Provost C, Joly J, Rogeaux O, Deschamps O. Incidence des événements infectieux survenus en cure thermale dans une population de curistes présu- més vulnérables : étude contrôlée longitudinale sur 738 patients. Press Therm Clim 2008;145:9-21

    BACKGROUND
  • Dubourg K, Grégoire P, Lagière J. La désinfection des piscines thermales de Dax. Press Therm Clim 2008;145:61-71

    BACKGROUND
  • Ducamp P. Fibromyalgie et thermalisme. 10ème Congrès National de la Fibromyalgie FNAFF. Nîmes, 13 octobre 2012.

    BACKGROUND
  • Grille OPTIMON évaluant le risque patient dans les études de recherche clinique institutionnelles

    BACKGROUND
  • 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

    BACKGROUND
  • Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.

    PMID: 19369473BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Philippe DUCAMP, MD

    Centre de Médecine et de Traumatologie du Sport

    PRINCIPAL INVESTIGATOR

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

Locations