Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action
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|ClinicalTrials.gov Identifier: NCT01538043|
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : July 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Other: local mud-pack therapy and balneotherapy||Phase 4|
OA is the most common rheumatic disease and the most important from the social-economic point of view because of its frequency, causing functional impairment and disability in older people, important health resource utilization and costs (drugs, physical therapies, spa therapy, surgical prothesis, early retirement).
Thermal therapy is one of the most commonly used non-pharmacological approaches for OA, but it is still being discussed and its role in modern medicine is still not clear. The action mechanisms of mud packs and thermal baths are not completely known, and it is difficult to distinguish the effects of thermal applications from the benefits that could be derived from a stay in a spa environment. Furthermore, there are no data about cost analysis of spa therapy in OA.
The aim of this study is to analyze for the first time the cost/effectiveness- cost/utility for spa therapy in comparison to conventional treatments in knee OA (one-year-follow-up)and to assess changes of some biomarkers or mediators of cartilage damage in order to identify new possible mechanisms of action of spa therapy in rheumatic diseases.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: local mud packs and thermal-mineral bath
50 patients with primary knee OA will be treated with daily local mud packs and thermal-mineral bath at Chianciano Terme Spa Center (Siena, Italy) for a total of 12 applications carried out over a period of two weeks
Other: local mud-pack therapy and balneotherapy
local mud-pack therapy and thermal-mineral bath at Chianciano Terme Spa Center (Siena, Italy) for a total of 12 applications carried out over a period of two weeks
Other Name: mud pack therapy
No Intervention: regular routine ambulatory care
50 patients, the control group, will continue regular routine ambulatory care
- cost/effectiveness- cost/utility for spa therapy compared to conventional treatments in knee osteoarthritis [ Time Frame: baseline and twelve months ]to evaluate for the first time cost/effectiveness- cost/utility for spa therapy compared to conventional treatments by a randomized single blind controlled trial in knee osteoarthritis
- changes of certain markers or mediators of cartilage damage [ Time Frame: baseline and two weeks ]to assess changes of certain markers or mediators of cartilage damage in order to identify new possible mechanisms of action of spa therapy in rheumatic diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538043
|Rheumatology Unit Azienda Ospedaliera Universitaria Senese|
|Siena, Italy, 53100|
|Principal Investigator:||Antonella Fioravanti, MD||Rheumatology Unit- Azienda Ospedaliera Universitaria Senese- Siena- Italy|