Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: local mud-pack therapy and balneotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from OA of the knee according to American College of Rheumatology (ACR) criteria and to standard radiography of the knee Exclusion Criteria: patients enrolled in other research protocols patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months patients affected by neoplastic diseases or in the last five years, with cardiovascular disease of recent onset, suffering from inflammatory diseases in the acute phase, serious impairment of hematopoietic, renal and hepatic systems, other inflammatory rheumatic or autoimmune disorders, or unable to complete the questionnaires and the daily diary for the collection of socio-economic data

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: local mud packs and thermal-mineral bath<br>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<br>* 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<br>* Other names: mud pack therapy;|
| No Intervention: regular routine ambulatory care<br>50 patients, the control group, will continue regular routine ambulatory care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost/effectiveness- cost/utility for spa therapy compared to conventional treatments in knee osteoarthritis | 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 | baseline and twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of certain markers or mediators of cartilage damage | 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. | baseline and two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cost-effectiveness analysis, Cost-utility analysis, Osteoarthritis, Spa therapy, Randomized clinical trial, Mechanisms of action