Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

September 10, 2013 updated by: University of Sao Paulo General Hospital

Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial

This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

Study Type

Interventional

Enrollment (Actual)

58

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

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05410-000
        • Instituto de Ortopedia e Traumatologia HC-FMUSP

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet the American College of Rheumatology criteria for knee Osteoarthritis
  • Varus malalignment of the knee
  • Absence of previous fracture on the index knee
  • Absence of previous surgery on the index knee
  • Absence of Rheumatoid Arthritis
  • No Intra-articular injection on the index knee in the past 6 months
  • Receiving usual care for Osteoarthritis for at least 6 months
  • Be able to understand and agree with the informed consent

Exclusion Criteria:

  • Undergo surgery during the study
  • Undergo Intra-articular injection during the study
  • Develop articular infection of the index joint during the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wedge
Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily
Other: Lateral wedge insole with subtalar strapping
Lateral wedge insole with subtalar strapping
Other Names:
  • Wedge
Sham Comparator: Neutral
Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily
Other: Neutral insole with subtalar strapping (sham)
Neutral insole with subtalar strapping (sham)
Other Names:
  • Neutral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: 24 weeks
Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle pain
Time Frame: 24 weeks
Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability
24 weeks

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Gustavo C Campos, MD, FMUSP

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.

Helpful Links

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

June 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 839/2011

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.

Clinical Trials on Osteoarthritis

Clinical Trials on Lateral wedge insole with subtalar strapping

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe