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A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Shoe-worn insoles (also known as orthotics) can provide symptomatic relief for people with knee osteoarthritis. However, given they act at the feet, and given that many people with knee osteoarthritis also report foot pain, it is important to assess the effects of these devices at both joints. We will conduct a multi-centre randomized pilot trial to determine feasibility and preliminary efficacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• medial tibiofemoral OA defined as definitive osteophytes and joint space narrowing in the medial compartment, as confirmed with radiographs

• history of knee pain longer than 6 months

• average self-reported knee pain of at least 3 out of 10 (using an 11-point numerical rating scale with terminal descriptors of 0 = no pain and 10 = worst pain imaginable) over the 6 months prior to baseline testing

• pain in the same foot/feet as the painful knee(s)

• ability to communicate in English

• show an immediate biomechanical response to the insoles. This final eligibility criterion will be determined from an in-person biomechanical assessment after participants have passed all previous eligibility screening.

Locations
Other Locations
Canada
Motion Analysis and Biofeedback Laboratory
RECRUITING
Vancouver
Contact Information
Primary
Natasha Krowchuk
natasha.krowchuk@ubc.ca
604-822-7948
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 36
Treatments
Experimental: Lateral wedge insoles (LWIs)
The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole.
Experimental: Lateral wedge plus custom arch support (LWAS)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Dalhousie University, Western University
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov