Clinical trial NCT02265029: Evaluation of Spa Therapy in the Treatment of Fibromyalgia
Official title: Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Rheumatism, Muscular
Keywords: fibromyalgia
rheumatism
fatigue syndrom
pain
spa treatment in rheumatology
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: Floralis
name: University Hospital, Grenoble
First posted: 2014-10-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.

Thermalgi is a 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 fibromyalgia.

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 fibromyalgia.

Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score (Fibromyalgia Impact Questionnaire) \> 39 will be randomized.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Handicap in everyday life
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Pain evolution
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Sleep quality
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Fatigue
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Depression
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Ability to cope
timeFrame: at baseline, 6 and 12 months
measure: Physical activity
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Medico economic impact
timeFrame: at baseline, 3, 6, 9 and 12 months
measure: Objective physical activity
timeFrame: at baseline, 3, and 6 months
measure: Objective sleep quality
timeFrame: at baseline, 3, and 6 months
Other outcomes:
Locations:
city: Aix les Bains
country: France
facility: station thermale AIX LES BAINS
city: Allevard
country: France
facility: station thermale ALLEVARD LES BAINS
city: Bourbon-Lancy
country: France
facility: station thermale BOURBON LANCY
city: Lamalou les Bains
country: France
facility: station thermale LAMALOU LES BAINS
city: Uriage les bains
country: France
facility: Station thermale URIAGE LES BAINS
Study officials:
affiliation: Hospital University Grenoble
name: Caroline MAINDET DOMINICI, MD
role: PRINCIPAL_INVESTIGATOR
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