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Orthotics

Shoe Insoles for Knee Osteoarthritis (MULTIWEDGE Trial)

N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess if shoe insoles can help people with knee osteoarthritis and foot pain. The study will be conducted at multiple centers and will test the effectiveness of these insoles on both

Who is the study for?
This trial is for people with knee osteoarthritis who've had knee pain for over 6 months, have specific changes in their knee joint seen on X-rays, and report a certain level of pain. They must also have foot pain on the same side as the affected knee and be able to communicate in English.
What is being tested?
The study is testing two types of shoe-worn insoles: one with just a lateral wedge (LWIs) and another combining a lateral wedge with custom arch support (LWAS). It aims to see if these can help relieve symptoms at both the feet and knees.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort or increased pain due to improper fit or alignment issues caused by the insoles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
External knee adduction moment impulse
Insoles Delivery
Recruitment - number of screened patients who are eligible
+3 more
Secondary study objectives
External knee flexion moment impulse
Rearfoot eversion peak
Self-reported foot function
+2 more
Other study objectives
Exit Interview

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lateral wedge plus custom arch support (LWAS)Experimental Treatment1 Intervention
The LWAS insoles will incorporate custom arch support along the medial edge as well as a 6 degree wedge along the lateral edge of the insole.
Group II: Lateral wedge insoles (LWIs)Experimental Treatment1 Intervention
The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole.

Find a Location

Who is running the clinical trial?

Western UniversityOTHER
29 Previous Clinical Trials
128,695 Total Patients Enrolled
Dalhousie UniversityOTHER
173 Previous Clinical Trials
401,818 Total Patients Enrolled
11 Trials studying Osteoarthritis
549 Patients Enrolled for Osteoarthritis
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,420 Total Patients Enrolled
26 Trials studying Osteoarthritis
1,942 Patients Enrolled for Osteoarthritis
~22 spots leftby Dec 2025
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