Wedged Insoles for Management of Knee Osteoarthritis

NCT02067208 | Completed DMC

• 1 other identifier: 23731-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Cartilage; Musculoskeletal; Biomechanics; Subtype; Footwear; Orthotics; Joint Loading

Outcome Measures

Primary Outcomes (1)

• KOOS pain score

  Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection

  baseline, 1-month, 2-months, 3-months

Secondary Outcomes (7)

• Adiposity

  baseline

• Knee biomechanics

  baseline

• PASE score

  baseline, 1-month, 2-months, 3-months

• UCLA Physical Activity Score

  baseline, 1-month, 2-months, 3-months

• Knee Adduction Moment

  baseline

Study Arms (2)

Waitlist Control

NO INTERVENTION

A waitlist control condition, where the participant receives no insole for 3 months. During this 3 month period, the participant will continue to be monitored for outcome variables.

Experimental wedged insole

EXPERIMENTAL

Either a medially wedged or laterally wedged footwear insole (whichever reduces knee joint mechanical loading more, as determined from subject-specific biomechanical tests), constructed using a 3D printer will be inserted into each participant's shoe. The participant will be asked to utilize this insole as much as possible throughout the day over the course of 3 months.

Device: wedged insole

Interventions

wedged insole DEVICE

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.

Also known as: orthotic

Experimental wedged insole

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Human Performance Laboratory, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

• Lewinson RT, Vallerand IA, Collins KH, Wiley JP, Lun VMY, Patel C, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee adduction moments for management of knee osteoarthritis:: A three month phase I/II randomized controlled trial. Gait Posture. 2016 Oct;50:60-68. doi: 10.1016/j.gaitpost.2016.08.027. Epub 2016 Aug 26.

  PMID: 27580080 DERIVED

• Lewinson RT, Collins KH, Vallerand IA, Wiley JP, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 3;15:405. doi: 10.1186/1471-2474-15-405.

  PMID: 25467955 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Ryan T Lewinson, BSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Kelsey HM Collins, BS

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Isabelle A Vallerand, BSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

• J Preston Wiley, MD, MPE

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Linda J Woodhouse, PhD, PT

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Raylene A Reimer, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Jay T Worobets, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Walter Herzog, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Darren J Stefanyshyn, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD Candidate

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 20, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CA (1)