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The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

NCT ID: NCT01942317

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Knee Osteoarthritis, Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Balneotherapy

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

Group Type EXPERIMENTAL

Balneotherapy

Intervention Type OTHER

Physiotherapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Balneotherapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Stefano Masiero

Professore Ordinario

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera-Università degli studi di Padova

Padua, Italy, Italy

Site Status

Countries

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Italy

Facility Contacts

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Stefano Masiero

Role: primary

Other Identifiers

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20232

Identifier Type: -

Identifier Source: secondary_id

20232

Identifier Type: OTHER

Identifier Source: secondary_id

20232

Identifier Type: -

Identifier Source: org_study_id