Spa Therapy in Knee Osteoarthritis (OA): Nancy-thermal
- Conditions
- Knee Osteoarthritis
- Interventions
- Other: Usual spa protocolOther: Active spa protocol
- Registration Number
- NCT01544647
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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:
1. To compare the efficacy of the 2 protocols at 3 months.
2. To determine the evolution of quality of life and medical care consumption
3. To describe postural abnormalities
4. To determine predictive factors to a favourable response at 3 and 6 months
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual spa protocol Usual spa protocol 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. Active spa protocol Active spa protocol 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.
- Primary Outcome Measures
Name Time Method Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery 6 months 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.
- Secondary Outcome Measures
Name Time Method medical care consumption 3 and 6 months particularly NSAIDs, pain killers
Achievement of the patient acceptable symptom state 3 and 6 months evolution of quality of life scores 3 and 6 months adverse events 3 and 6 months postural abnormalities 3 and 6 months 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.
Trial Locations
- Locations (1)
Nancy university hospital center
🇫🇷Nancy, France