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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local mud packs and thermal-mineral bath | Active Comparator | 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 |
|
| regular routine ambulatory care | No Intervention | 50 patients, the control group, will continue regular routine ambulatory care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local mud-pack therapy and balneotherapy | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonella Fioravanti, MD | Rheumatology Unit- Azienda Ospedaliera Universitaria Senese- Siena- Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Unit Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14618120 | Background | Fioravanti A, Valenti M, Altobelli E, Di Orio F, Nappi G, Crisanti A, Cantarini L, Marcolongo R. Clinical efficacy and cost-effectiveness evidence of spa therapy in osteoarthritis. The results of "Naiade" Italian Project. Panminerva Med. 2003 Sep;45(3):211-7. | |
| 17106661 | Background | Cantarini L, Leo G, Giannitti C, Cevenini G, Barberini P, Fioravanti A. Therapeutic effect of spa therapy and short wave therapy in knee osteoarthritis: a randomized, single blind, controlled trial. Rheumatol Int. 2007 Apr;27(6):523-9. doi: 10.1007/s00296-006-0266-5. Epub 2006 Nov 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 14, 2016 | |
| Reset | Nov 2, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 14, 2016 | Nov 2, 2016 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001452 | Balneology |
| D009094 | Mud Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 19884812 | Background | Fioravanti A, Iacoponi F, Bellisai B, Cantarini L, Galeazzi M. Short- and long-term effects of spa therapy in knee osteoarthritis. Am J Phys Med Rehabil. 2010 Feb;89(2):125-32. doi: 10.1097/PHM.0b013e3181c1eb81. |
| 20237929 | Background | Fioravanti A, Cantarini L, Bacarelli MR, de Lalla A, Ceccatelli L, Blardi P. Effects of spa therapy on serum leptin and adiponectin levels in patients with knee osteoarthritis. Rheumatol Int. 2011 Jul;31(7):879-82. doi: 10.1007/s00296-010-1401-x. Epub 2010 Mar 18. |
| 21120502 | Background | Fioravanti A, Cantarini L, Guidelli GM, Galeazzi M. Mechanisms of action of spa therapies in rheumatic diseases: what scientific evidence is there? Rheumatol Int. 2011 Jan;31(1):1-8. doi: 10.1007/s00296-010-1628-6. Epub 2010 Dec 1. |
| 21573819 | Background | Fioravanti A, Giannitti C, Bellisai B, Iacoponi F, Galeazzi M. Efficacy of balneotherapy on pain, function and quality of life in patients with osteoarthritis of the knee. Int J Biometeorol. 2012 Jul;56(4):583-90. doi: 10.1007/s00484-011-0447-0. Epub 2011 May 15. |
| 19734131 | Background | Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3. |
| 27723261 | Derived | Ciani O, Pascarelli NA, Giannitti C, Galeazzi M, Meregaglia M, Fattore G, Fioravanti A. Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: An Economic Evaluation Alongside a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):966-972. doi: 10.1002/acr.23116. Epub 2017 Jun 7. |
| 27696739 | Derived | Chung KC, Kotsis SV, Burns PB, Burke FD, Wilgis EFS, Fox DA, Kim HM. Seven-Year Outcomes of the Silicone Arthroplasty in Rheumatoid Arthritis Prospective Cohort Study. Arthritis Care Res (Hoboken). 2017 Jul;69(7):973-981. doi: 10.1002/acr.23105. Epub 2017 Jun 9. |
| 25750093 | Derived | Fioravanti A, Giannitti C, Cheleschi S, Simpatico A, Pascarelli NA, Galeazzi M. Circulating levels of adiponectin, resistin, and visfatin after mud-bath therapy in patients with bilateral knee osteoarthritis. Int J Biometeorol. 2015 Nov;59(11):1691-700. doi: 10.1007/s00484-015-0977-y. Epub 2015 Mar 7. |