Recruiting NCT06251167
A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lateral wedge insoles (LWIs), Lateral wedge plus custom arch support (LWAS).
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
Overview
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.
Interventions
- Device Lateral wedge insoles (LWIs)
Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge. - Device Lateral wedge plus custom arch support (LWAS)
Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then upload
Primary outcome measures
- Recruitment - number of screened patients who are eligible [Time frame: from onset of recruitment through study completion]
- Retention - proportion of assessments with complete outcome measures data [Time frame: immediately after the intervention]
- Insoles Delivery [Time frame: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months]
- Self-reported knee pain [Time frame: Baseline, 3 Months]
- Self-reported foot pain [Time frame: Baseline, 3 Months]
- External knee adduction moment impulse [Time frame: Baseline, 3 Months]
Secondary outcome measures (5)
- Self-reported overall physical function [Time frame: Baseline, 3 Months]
- Self-reported foot function [Time frame: Baseline, 3 Months]
- External knee flexion moment impulse [Time frame: Baseline, 3 Months]
- Self-selected gait speed [Time frame: Baseline, 3 Months]
- Rearfoot eversion peak [Time frame: Baseline, 3 Months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- radiographic evidence of more lateral tibiofemoral OA than medial
- knee surgery or intra-articular injection within the previous 6 months
- current or recent (within 6 months) corticosteroid use for any reason
- presence of a systemic arthritic condition
- history of knee joint replacement or tibial osteotomy
- any other condition affecting lower limb function
- current usage of shoe-worn insoles, or planning to acquire footwear modifications in the next 6 months
- any previous experience with insoles that resulted in increased lower limb pain or a self- or clinician-initiated termination of use.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Motion Analysis and Biofeedback Laboratory — Vancouver
Identifiers
NCT: NCT06251167 · H22-03584