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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: local mud-pack therapy and balneotherapy

• Registration Number: NCT01538043
• Lead Sponsor: University of Siena

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).

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local mud packs and thermal-mineral bath	local mud-pack therapy and balneotherapy	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

Primary Outcome Measures

Name	Time	Method
cost/effectiveness- cost/utility for spa therapy compared to conventional treatments in knee osteoarthritis	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

Secondary Outcome Measures

Name	Time	Method
changes of certain markers or mediators of cartilage damage	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.

Trial Locations

Locations (1)

Rheumatology Unit Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy