The Role of Balneotherapy in Obese Patients With Knee Ost... | NCT01942317

Studies
The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis

NCT01942317

Sponsor

University of Padova

Status

Unknown status

Last Update Posted

Sep 13, 2013Estimated

Enrollment

74Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthritis, Obesity

Interventions

Balneotherapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
20232
20232	Other Identifier	COMITATO ETICO PER LA SPERIMENTAZIONE - AZIENDA OSPEDALIERA DI PADOVA, ITALY

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Mar 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Sep 10, 2013

First Submission Date that Met QC Criteria

Sep 10, 2013

First Posted Date

Sep 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2013

Last Update Posted Date

Sep 13, 2013Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Balneotherapy	Experimental	16 balneotherapy treatments, each of 45 minutes, twice a week, for 8 consecutive weeks	Other: Balneotherapy
Physiotherapy	No Intervention	16 physiotherapy treatments (no balneotherapy), each of 45 minutes, twice a week, for 8 consecutive weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Balneotherapy	Other		Balneotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera-Università degli studi di Padova		Padua	Italy	35128	Italy

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D009765	Obesity

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided