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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538043
• Other study ID #: TAC2010
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2012
• Last updated: July 1, 2014
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	Rheumatology Unit Azienda Ospedaliera Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. Epub 2006 Nov 15. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Forestier R, Desfour H, Tessier JM, Françon 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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