Recruiting

Shoe-worn Insoles

Sponsor:

University of British Columbia

Code:

NCT06251167

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Lateral wedge insoles (LWIs)

Lateral wedge plus custom arch support (LWAS)

Study Details

Brief 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.

Conditions

Knee Osteoarthritis

Study ID

NCT06251167

Start date

Mar 4, 2024

Status verified date

May, 2026

Completion date

Apr 10, 2027

Anticipated

Primary completion date

Apr 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

31 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 uploads this foot data to a secure patient record system that is used for insole fabrication. The LWAS insoles will be comprised of variable density material (more dense laterally than medially) and milled directly to produce a full-length shell. The 6 degree wedge will be incorporated along the full lateral length of the insoles.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Natasha Krowchuk

604-822-7948natasha.krowchuk@ubc.ca

Locations

Motion Analysis and Biofeedback Laboratory

Recruiting

Vancouver, British Columbia, Canada, V5R 3N9

Contacts

Natasha Krowchuk

6048227948

More Information

Sponsor

University of British Columbia

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • Knee Osteoarthritis
  • Orthotics
  • Foot pain
  • Biomechanics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-06-01.