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Orthotics

Lateral wedge plus custom arch support (LWAS) for 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

MULTIWEDGE Trial 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.Check my eligibility
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.See study design
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.

MULTIWEDGE Trial 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

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

MULTIWEDGE 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
26 Previous Clinical Trials
128,505 Total Patients Enrolled
Dalhousie UniversityOTHER
167 Previous Clinical Trials
403,102 Total Patients Enrolled
11 Trials studying Osteoarthritis
549 Patients Enrolled for Osteoarthritis
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,082 Total Patients Enrolled
26 Trials studying Osteoarthritis
1,931 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants enrolled in this clinical investigation?

"Affirmative, the details available on clinicaltrials.gov indicate an ongoing search for suitable participants in this medical trial. The study was originally posted on March 4th, 2024, and last revised on March 7th, 2024. Recruitment aims to enlist a total of 36 individuals from a single designated site."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"Affirmative. Records on clinicaltrials.gov indicate that this research is presently enrolling participants. The trial was first listed on March 4, 2024, and the latest update occurred on March 7, 2024. In total, there is a requirement for 36 volunteers at one designated location."

Answered by AI

What specific objectives does this medical study aim to fulfill?

"The main focus of this trial, assessed immediately post-intervention, is self-reported knee discomfort. Secondary assessments consist of rearfoot eversion peak—measured by tracking markers on bony landmarks as patients walk over instrumented surfaces with high-speed cameras; external knee flexion moment impulse—determined using identical techniques to the external knee adduction moment impulse calculation; and self-selected gait speed—evaluated through biomechanical gait analyses."

Answered by AI

Who else is applying?

What site did they apply to?
Motion Analysis and Biofeedback Laboratory
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

The cingal did not work as effectively this time.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
Michael Hunt 2024. "A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06251167.
All > Knee Osteoarthritis
~24 spots leftby Dec 2025
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