Laterally Wedged Insoles for Patients With Knee Osteoarthritis

January 8, 2013 updated by: Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences

The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. Because of the high incidence of knee osteoarthritis in the elderly and the seriousness of drug effects in this age group and lack of controlled study in our country regarding the possible benefits or lack of benefit of laterally wedged insoles in patients with knee osteoarthritis and also due to strike, and results of mixed in other studies, this study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

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

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic medial femorotibial knee OA,
  • Daily knee pain for at least 1 month in the last 3 months,
  • Radiographic evidence of medial femorotibial knee OA,
  • Normal erythrocyte sedimentation rate.

Exclusion Criteria:

  • Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography,
  • Knee joint lavage in past 3 months,
  • Intra-articular corticosteroid injection during the past 3 months,
  • Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laterally wedged insoles
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.
Procedure: Laterally wedged insoles
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in knee pain severity after 2 months.
Time Frame: Up to 2 months
The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in knee's functional degree after 2 months.
Time Frame: Up to 2 months.
Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy.
Up to 2 months.

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2012

Primary Completion (ANTICIPATED)

August 1, 2013

Study Completion (ANTICIPATED)

October 1, 2013

Study Registration Dates

First Submitted

December 28, 2012

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13913008

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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