Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: Lateral wedge insole with subtalar strapping; Other: Neutral insole with subtalar strapping (sham)

• Registration Number: NCT01739296
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-07
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wedge	Lateral wedge insole with subtalar strapping	Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily
Neutral	Neutral insole with subtalar strapping (sham)	Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily

Primary Outcome Measures

Name	Time	Method
Symptoms	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 Outcome Measures

Name	Time	Method
Ankle pain	24 weeks	Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia HC-FMUSP; 🇧🇷 São Paulo, SP, Brazil