Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 283
- Locations
- 1
- Primary Endpoint
- Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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:
- To compare the efficacy of the 2 protocols at 3 months.
- To determine the evolution of quality of life and medical care consumption
- To describe postural abnormalities
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
Time Frame: 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 Outcomes
- medical care consumption(3 and 6 months)
- 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)