Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action
This study is ongoing, but not recruiting participants.
Sponsor:
University of Siena
Information provided by (Responsible Party):
fioravanti antonella, University of Siena
ClinicalTrials.gov Identifier:
NCT01538043
First received: February 13, 2012
Last updated: February 23, 2012
Last verified: February 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 13, 2012 | ||||
| Last Updated Date | February 23, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
cost/effectiveness- cost/utility for spa therapy compared to conventional treatments in knee osteoarthritis [ Time Frame: baseline and twelve months ] [ Designated as safety issue: Yes ] 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01538043 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
changes of certain markers or mediators of cartilage damage [ Time Frame: baseline and two weeks ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action | ||||
| Official Title ICMJE | Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action | ||||
| Brief Summary | The aim of this study is to evaluate both cost/effectiveness- cost/utility and the possible mechanisms of action of spa therapy in patients with primary knee osteoarthritis (OA). |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis, Knee | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | May 2013 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01538043 | ||||
| Other Study ID Numbers ICMJE | TAC2010 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | fioravanti antonella, University of Siena | ||||
| Study Sponsor ICMJE | University of Siena | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Siena | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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