Status:
COMPLETED
Evaluation of Spa Therapy in the Treatment of Fibromyalgia
Lead Sponsor:
Association Francaise pour la Recherche Thermale
Collaborating Sponsors:
Floralis
University Hospital, Grenoble
Conditions:
Fibromyalgia
Rheumatism, Muscular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibr...
Detailed Description
THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromy...
Eligibility Criteria
Inclusion
- both sexes, more than 18 years old patients
- available for a spa treatment in rheumatology during 18 days (immediate or late spa) and a follow-up period of 12 months
- with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment for at least 3 months
- with a FIQ score \> or = 39 (fibromyalgia moderate to severe)
- voluntary to participate to the study, informed consent form signed after appropriate information
- affiliation to the social security system or equivalent
Exclusion
- contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
- no previous spa treatment in rheumatology within 1 year prior to inclusion
- substantial variation of the therapeutic coverage in the previous 3 months the inclusion (change of medicinal class, starting up of a réentrainement in the effort or a cognitivio-behavioral technique)
- subject with an other chronic severe disease (severe asthma, severe cardiac insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease, inflammatory colitis...)
- subject participating to an other clinical study inerventionnal
- pregnancy, parturient or breast feeding
- no psychiatric illness or social situation that would preclude study compliance
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT02265029
Start Date
September 1 2014
End Date
October 1 2018
Last Update
January 11 2019
Active Locations (5)
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1
station thermale AIX LES BAINS
Aix-les-Bains, France, 73100
2
station thermale ALLEVARD LES BAINS
Allevard, France, 38580
3
station thermale BOURBON LANCY
Bourbon-Lancy, France, 71140
4
station thermale LAMALOU LES BAINS
Lamalou-les-Bains, France, 34240