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Clinical Trials/NCT01739296
NCT01739296
Completed
Not Applicable

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

University of Sao Paulo General Hospital1 site in 1 country58 target enrollmentJune 2011
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ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Sao Paulo General Hospital
Enrollment
58
Locations
1
Primary Endpoint
Symptoms
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
July 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Ankle pain(24 weeks)

Study Sites (1)

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