Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI. In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical improvement for patients, as demonstrated in the Thermarthrose study. This center is near Montpellier and could improve patients localised in this area.
Methods: randomised prospective clinical trial of patients with knee osteoarthritis. The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group received 18 days of therapy over 3 weeks after the 6-month follow-up visit. Follow-up was at 3 and 6 months, by a visit to the examination. The hypothesis of our study is to demonstrate clinical improvement at six months. The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
The spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily)
Achievement of minimal clinically important improvement (MCII) at 6 months
The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoart
Time frame: 30 months
Achievement of minimal clinically important improvement (MCII) at 3 months
The second outcome measure is the number of patients achieving minimal clinically important improvement (MCII) at 3 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score, and also the safety.
Time frame: 30 months
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