An interventional study of Usual spa protocol and Active spa protocol in Knee Osteoarthritis, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment
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.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 283 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria are:
Non inclusion criteria are:
4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
Other: Usual 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.
Other: Active spa protocol
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
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.
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.
Time frame: 6 months
Achievement of the patient acceptable symptom state
Time frame: 3 and 6 months
evolution of quality of life scores
Time frame: 3 and 6 months
medical care consumption
particularly NSAIDs, pain killers
Time frame: 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.
Time frame: 3 and 6 months
adverse events
Time frame: 3 and 6 months
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France