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Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.
The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement 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 osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.
The secondary objectives are:
This is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee OA.
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. In the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.
Data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual spa protocol | Active Comparator | 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. |
|
| Active spa protocol | Active Comparator | 4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual spa protocol | Other | In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery | The main outcome 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 osteoarthritis index function score and no knee surgery. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of the patient acceptable symptom state | 3 and 6 months | |
| evolution of quality of life scores | 3 and 6 months | |
| medical care consumption |
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Inclusion criteria are:
Non inclusion criteria are:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nancy university hospital center | Nancy | 54000 | France |
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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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| Active spa protocol | Other | 4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week. |
|
particularly NSAIDs, pain killers |
| 3 and 6 months |
| postural abnormalities | The method used aimed at evaluating two modalities of postural regulation - quiet stance and during movement - and their related neurosensory organization. Postural control during quiet stance will be evaluated with and without sensory conflict by a static posturographic test and by a sensory organization test; postural control during movement will be evaluated by a dynamic posturographic test with slow sinusoidal oscillations. | 3 and 6 months |
| adverse events | 3 and 6 months |
| D012216 |
| Rheumatic Diseases |