Wedged Insoles for Management of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067208
• Other study ID #: 23731-01
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: November 30, 2015
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these insoles typically reduce knee abduction moments (KAM) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for OA management, recent research has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In such cases, a medial wedge may be more appropriate.

The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months for patients with knee OA. It is hypothesized that pain reduction will be directly related to KAM reduction.

Forty-six participants with knee OA will be recruited to participate. Each will undergo biomechanical gait analysis to determine the wedge type that most greatly reduces knee adduction moments. In addition, each participant will undergo a Dual Energy X-Ray Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury history. Participants will be randomized into either a wait list control group (no insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months.

Changes to pain, function, comfort and physical activity from baseline to 3 months will be assessed within the control and experimental groups. Regression analyses will be conducted on the experimental group to determine if a relationship exists between reduced KAMs and reduced pain over 3 months. Comparisons will also be made between the control and experimental groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Physician-diagnosed knee osteoarthritis (using American College of Rheumatology clinical and radiographic criteria)

• Kellgren-Lawrence grade 1, 2, 3 or 4

• Primary symptoms and disease location must be attributed to medial tibiofemoral compartment

• KOOS pain of 75 points or lower (where 0 is worst pain and 100 is no pain)

Exclusion Criteria:

• X-ray older than 2 years

• Viscosupplementation within past 6 months

• Cortisone injection in past 3 months

• Narcotic pain medication within past 3 months

• Use of knee unloading brace interventions in past 2 months

• Recent (past 6 months) knee or neuromuscular injury that could bias pain assessments or gait analysis results

• No KAM reduction with either lateral or medial wedge insole

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• wedged insole
Wedged insoles are designed to reduce frontal plane knee joint mechanical loads during gait. Specifically, they can alter the knee adduction moment during gait - a variable associated with progression of knee osteoarthritis. In the experimental arm of this study, participants will undergo biomechanical gait analysis to identify the wedged insole that reduces the moments the most. The two options are medial wedge, where the medial aspect of the foot is elevated relative to the lateral aspect, and the lateral wedge, where the lateral wedge is elevated relative to the medial aspect.

Locations

Country	Name	City	State
Canada	Human Performance Laboratory, University of Calgary	Calgary	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
University of Calgary	Alberta Innovates Health Solutions, Canadian Institutes of Health Research (CIHR), Killam Trusts, Natural Sciences and Engineering Research Council, Canada, New Balance Athletic Shoe, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS pain score	Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection	baseline, 1-month, 2-months, 3-months	No
Secondary	Adiposity	Measured using Dual Energy X-Ray Absorptiometry (DXA) scan	baseline	No
Secondary	Knee biomechanics	Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse).	baseline	No
Secondary	PASE score	Physical Activity Scale for the Elderly (PASE)	baseline, 1-month, 2-months, 3-months	No
Secondary	UCLA Physical Activity Score	Scale evaluating physical activity levels	baseline, 1-month, 2-months, 3-months	No
Secondary	Knee Adduction Moment	Calculated using inverse dynamics	baseline	No
Secondary	Footwear Comfort	Evaluated using 100mm visual analog scale	baseline	No
Secondary	KOOS subsection and aggregate scores	All other KOOS sections (excluding pain, which is primary outcome)	baseline, 1-month, 2-months, 3-months	No