Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

University of Sao Paulo General Hospital

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: Neutral insole with subtalar strapping (sham); Other: Lateral wedge insole with subtalar strapping

Study type: Interventional

Funder types: Other

Identifiers

NCT01739296

839/2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Wedge

Experimental group

Description:

Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily

Treatment:

Other: Lateral wedge insole with subtalar strapping

Neutral

Sham Comparator group

Description:

Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily

Treatment:

Other: Neutral insole with subtalar strapping (sham)