The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

September 10, 2013 updated by: Stefano Masiero, University of Padova
The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy, 35128
        • Azienda Ospedaliera-Università degli studi di Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obesity II-III grade (BMI 35-45 kg/m2)
  • knee pain
  • patient compliance to the treatment

Exclusion Criteria:

  • BMI<34,9kg/m2 or BMI> 45,1kg/m2
  • previous knee surgery
  • complicated diabetes mellitus
  • ischemic cardiomyopathy and heart failure
  • acute phase of osteoarthritis
  • varicose veins, deep venous thrombosis (DVT)
  • cancer
  • cutaneous lesions
  • NSAIDs administration <1 week before the treatment
  • knee infiltration <2 months before the treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balneotherapy
16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks
Other: Balneotherapy
No Intervention: Physiotherapy
16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee pain measurement with Visual Analogue Scale (VAS)
Time Frame: At the begining and at the end of the treatment. After 6 months of the end of therapy
At the begining and at the end of the treatment. After 6 months of the end of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee range of motion
Time Frame: At the begining and at the end of the treatment. After 6 months of the end of therapy
At the begining and at the end of the treatment. After 6 months of the end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20232 (Other Identifier: COMITATO ETICO PER LA SPERIMENTAZIONE - AZIENDA OSPEDALIERA DI PADOVA, ITALY)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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