Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01739296

Enrollment

Registered

2012-12-03

Start date

2011-06-30

Completion date

2012-07-31

Last updated

2013-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis, osteoarthritis, knee, foot orthoses, orthotic insoles

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.

Interventions

OTHERNeutral insole with subtalar strapping (sham)

Neutral insole with subtalar strapping (sham)

OTHERLateral wedge insole with subtalar strapping

Lateral wedge insole with subtalar strapping

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026