Evaluation of Spa Therapy in the Treatment of Fibromyalgia (THERMALGI)

Association Francaise pour la Recherche Thermale

Status: Completed

Conditions: Fibromyalgia; Rheumatism, Muscular

Treatments: Other: Immediate spa treatment; Other: Late spa treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02265029

DCIC/13/68

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Immediate spa treatment

Active Comparator group

Description:

Spa treatment during 18 days soon after randomization : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)

Treatment:

Other: Immediate spa treatment

Late SPA treatment

Sham Comparator group

Description:

Spa treatment during 18 days soon after 6 months visit : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)

Treatment:

Other: Late spa treatment