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| Name | Class |
|---|---|
| FONTCAUDE's Vichy SPA center, Juvignac | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal care | Experimental | Spa Treatment realised daily 6 days a week during 18 days |
|
| Standard Care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spa Treatment | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 months |
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Inclusion criteria:
Exclusion criteria:
Realization of a water cure in the last 6 months
Infiltration of the knee of less than 3 months
Impossibility to sign the informed consent or which for reasons geographical, social or psychological could not be regularly followed,
Person major placed under guardianship or trusteeship,
Private person of freedom by court or administrative order, nobody being the object of a legal protective measure,
Patient already included in an interventional clinical protocol,
Pregnant women
Contraindication in the water cure:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel TAVARES, PH | CHU de Montpellier | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D012216 |
| Rheumatic Diseases |