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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
fioravanti antonella, University of Siena
ClinicalTrials.gov Identifier:
NCT01538043
First received: February 13, 2012
Last updated: July 1, 2014
Last verified: July 2014

February 13, 2012
July 1, 2014
December 2010
May 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01538043 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action
Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Osteoarthritis, Knee
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
  • Active Comparator: local mud packs and thermal-mineral bath
    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
    Intervention: Other: local mud-pack therapy and balneotherapy
  • No Intervention: regular routine ambulatory care
    50 patients, the control group, will continue regular routine ambulatory care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01538043
TAC2010
Yes
fioravanti antonella, University of Siena
University of Siena
Not Provided
Principal Investigator: Antonella Fioravanti, MD Rheumatology Unit- Azienda Ospedaliera Universitaria Senese- Siena- Italy
University of Siena
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP