Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis

Study Overview
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Brief Summary
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Assessment of the effect of spa treatment on the functional severity of arthrosis. Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment. Primary outcome measure: Measuring the effect of spa treatment on functional severity of arthrosis Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference) Secondary outcome measures Quantitative evaluation of pain Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after Quantitative evaluation of WOMAC Comparison of mean WOMAC between enrollment and 6 months after Impact of spa treatment on the patient's metabolism Height and Weight (BMI calculation) Blood pressure Heart rate Quality of life 36-Item Short Form (SF36) at enrollment, 3 months and 6 months EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months Opinion of doctor and patient Semi-quantitative scale collected at enrollment, 3 months and 6 months Treatment follow-up Self-evaluation of pain Self-evaluation of pain with VAS pain scale every 6 week

Detailed Description
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Arthrosis and rheumatic diseases on the whole consist in a huge and frequent public health problem, with consequences notably including the well-known pain phenomena. Spa treatments are part of the mainstream therapeutic arsenal of non-medical treatments proposed to this kind of patients. A recent French study estimated the direct cost of arthrosis in France to 1.6 billion euros in 2002. Half of it was attributable to hospital expenses (800 million euros). Arthrosis required 13 million consultations and drug expenses amounting to 570 million euros. These expenses were increased by 156% compared to 1993 due to the raise of the number of treated patients (+54%) and the cost for each patient (+2.5% per year). This study concerned patients with arthrosis on the lower limbs, with an significant portion of these expenses attributable to the disease. Different thermal clinical trials of good quality have led to the recognition of spa in the treatment of chronic low back pain. Several controlled and randomized prospective trials already evaluated the effect of spa treatment for the other main indications claimed by crenotherapy in rheumatology : chronic low back pain, coxarthrosis, hand arthrosis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis, chronic cervicalgia. The THERMARTHROSE study by Forestier has demonstrated the efficacy of spa treatment as a rheumatologic indication for gonarthrosis on WOMAC and VAS pain scale. Following the model of this study, the sponsor chose to use the WOMAC as the primary endpoint for the VALS study. It has been developed by Bellamy in 1988, and it is a functional index aimed on the locomotor system. Nowadays, the WOMAC is more used than the Lequesne index because it has better internal consistency reliability. However, complementary validation efforts were necessary to calculate the minimal clinically important difference whereas the pertinence of the Lequesne index is immediately perceptible, being purely qualitative. With studies in thermal environment, spa treatment is a composite entity including the effect of water itself, but also kinesiotherapy, rest, education… The spa of Vals-les-Bains wishes to obtain a new therapeutic orientation: the rheumatologic orientation. According to the recommendations of the Academy of Medicine, a prolonged observation of a cohort with repeated measures is required for any spa wishing to acquire the accreditation for a new orientation. Toward this goal, the sponsor wish to undertake a prospective study with repeated measures in order to analyze the evolution at 6 month of the clinical state of patients with a rheumatologic disease on the lower limbs or the rachis and taken over for spa treatment at Vals-les-Bains. Since rheumatologic treatments at Vals-les-Bains are not covered by the health insurance, they will not be billed to the patients

Official Title
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Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment

Conditions
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Osteoarthritis, Knee, Pain

Intervention / Treatment
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* Other: Spa Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with arthrosis or other rheumatic disease, located on the lower limbs or the rachis Rheumatic indication for spa treatment Diminution of mobility Affiliation to the French social security system or equivalent Available for a 6-months follow-up and an 18-days spa treatment Exclusion Criteria: Pregnancy, parturient or breast feeding Psychiatric illness or social situation that would preclude study compliance Contraindication to spa treatment Predictable intolerance to thermal treatment

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spa Treatment<br>Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm. | Other: Spa Treatment<br>* Bath with immersion shower Overall shower, penetrating shower Multiple local application cataplasm Single local application cataplasm Inhalation or collective steam bath Individual physiotherapy technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the effect of spa treatment on functional severity of arthrosis | Proportion of patients with a WOMAC score augmented by 9 or more, at 6 months compared to baseline (minimal clinically important difference) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative evaluation of pain | Comparison of mean VAS pain scale between baseline, 3 and 6 months | at baseline, 3 and 6 months | 
| Quantitative evaluation of WOMAC | Comparison of mean WOMAC between baseline, 3 months and 6 months | at baseline, 3 and 6 months | 
| Patient's BMI | weight and height will be combined to report BMI in kg/m2 | at baseline, 3 and 6 months | 
| Quality of life | SF36 questionnaire at baseline, 3 and 6 months | at baseline, 3 and 6 months | 
| Quality of life | EQ5D questionnaire at baseline, 3 and 6 months | at baseline, 3 and 6 months | 
| Opinion of doctor and patient | Semi-quantitative scale collected at baseline, 3 and 6 months | at baseline, 3 and 6 months | 
| Number of treatments prescribed | Type of treatments prescribed at baseline, 3 and 6 months will be collected | at baseline, 3 and 6 months | 
| Changes in treatments prescribed | changes in treatments prescribed at baseline, 3 and 6 months will be collected | at baseline, 3 and 6 months | 
| Treatments duration | Duration of treatments prescribed at baseline, 3 and 6 months will be collected | at baseline, 3 and 6 months | 
| Self-evaluation of pain | Self-evaluation of pain with VAS pain scale at baseline, 1.5, 3, 4.5 and 6 months | at baseline, 1.5, 3, 4.5 and 6 months | 
| patient examination | heart rate | at baseline, 3 and 6 months |