Evaluation of Spa Therapy in the Treatment of Fibromyalgia

Association Francaise pour la Recherche Thermale220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

220

Conditions

Fibromyalgia Rheumatism, Muscular

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

station thermale AIX LES BAINS

Aix-les-Bains, France

station thermale ALLEVARD LES BAINS

Allevard, France

station thermale BOURBON LANCY

Bourbon-Lancy, France

station thermale LAMALOU LES BAINS

Lamalou-les-Bains, France

Station thermale URIAGE LES BAINS

Uriage-les-Bains, France

Outcomes

Primary Outcomes

Handicap in everyday life

Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline

Time frame: 6 months

Secondary Outcomes

Quality of life

1. Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome. 2. EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months. 3. Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months.