Evaluation of Spa Therapy in the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study

Conditions
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Fibromyalgia, Rheumatism, Muscular

Intervention / Treatment
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* Other: Immediate spa treatment
* Other: Late spa treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate spa treatment<br>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,...) | Other: Immediate spa treatment<br>* spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)<br>* Other names: Spa treatment soon after randomisation;|
| Sham Comparator: Late SPA treatment<br>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,...) | Other: Late spa treatment<br>* spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)<br>* Other names: Spa treatment after 6 months visit in the study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handicap in everyday life | Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome. EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months. Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months. | at baseline, 3, 6, 9 and 12 months | 
| Pain evolution | Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months | at baseline, 3, 6, 9 and 12 months | 
| Sleep quality | Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months | at baseline, 3, 6, 9 and 12 months | 
| Fatigue | Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months | at baseline, 3, 6, 9 and 12 months | 
| Depression | Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months | at baseline, 3, 6, 9 and 12 months | 
| Ability to cope | Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months | at baseline, 6 and 12 months | 
| Physical activity | Evolution of Baecke score between baseline, 3, 6, 9 and 12 months evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months | at baseline, 3, 6, 9 and 12 months | 
| Medico economic impact | Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort. | at baseline, 3, 6, 9 and 12 months | 
| Objective physical activity | Record of day activity during one week with actigraphy at baseline, 3 and 6 months | at baseline, 3, and 6 months | 
| Objective sleep quality | Record of night activity and cardiac variability at baseline, 3 and 6 months | at baseline, 3, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, rheumatism, fatigue syndrom, pain, spa treatment in rheumatology