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The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Balneotherapy

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis, Obesity

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Azienda Ospedaliera-Università degli studi di Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Balneotherapy

Physiotherapy

Arm Description

16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks

16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks

Outcomes

Primary Outcome Measures

Knee pain measurement with Visual Analogue Scale (VAS)

Secondary Outcome Measures

Knee range of motion

Full Information

NCT ID

NCT01942317

First Posted

September 10, 2013

Last Updated

September 10, 2013

Sponsor

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT01942317

Brief Title

The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Padova

4. Oversight

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Obesity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Balneotherapy

Arm Type

Experimental

Arm Description

16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks

Arm Title

Physiotherapy

Arm Type

No Intervention

Arm Description

16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks

Intervention Type

Other

Intervention Name(s)

Balneotherapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Knee range of motion

Time Frame

At the begining and at the end of the treatment. After 6 months of the end of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Azienda Ospedaliera-Università degli studi di Padova

City

Padua

ZIP/Postal Code

35128

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefano Masiero

Phone

+390498211270

stef.masiero@unipd.it

First Name & Middle Initial & Last Name & Degree

Stefano Masiero

12. IPD Sharing Statement

Learn more about this trial

The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

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