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
  Purpose

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).


Condition Intervention Phase
Osteoarthritis, Knee
Other: local mud-pack therapy and balneotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Spa Therapy in Knee Osteoarthritis: Study on Cost/Effectiveness - Cost/Utility and Possible Mechanisms of Action

Resource links provided by NLM:


Further study details as provided by University of Siena:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: December 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
No Intervention: regular routine ambulatory care
50 patients, the control group, will continue regular routine ambulatory care

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538043

Locations
Italy
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Sponsors and Collaborators
University of Siena
Investigators
Principal Investigator: Antonella Fioravanti, MD Rheumatology Unit- Azienda Ospedaliera Universitaria Senese- Siena- Italy
  More Information

Publications:

Responsible Party: fioravanti antonella, medical doctor, University of Siena
ClinicalTrials.gov Identifier: NCT01538043     History of Changes
Other Study ID Numbers: TAC2010
Study First Received: February 13, 2012
Last Updated: July 1, 2014
Health Authority: Italy:ethics committee Azienda Ospedaliera-University of Siena

Keywords provided by University of Siena:
Cost-effectiveness analysis
Cost-utility analysis
Osteoarthritis
Spa therapy
Randomized clinical trial
Mechanisms of action

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014