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NCT Number: NCT06251167

A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Analysis and Biofeedback Laboratory

Vancouver, British Columbia, V5R 3N9, Canada

Location status: Recruiting

Location contact

Natasha Krowchuk

CONTACT

6048227948

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lateral wedge insoles (LWIs)

Device

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)

Device

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 outcomes

  1. Recruitment - number of screened patients who are eligible

    Time frame: from onset of recruitment through study completion

    The number of screened patients determined eligible to be enrolled in the study.

  2. Retention - proportion of assessments with complete outcome measures data

    Time frame: immediately after the intervention

    Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol.

  3. Insoles Delivery

    Time frame: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months

    Time between foot scan assessment and delivery of insoles. Given that insoles will be manufactured centrally and distributed to the sites, we are interested in assessing the expected timeframe for enrollment in the study.

  4. Self-reported knee pain

    Time frame: Baseline, 3 Months

    Knee pain will be measured by the Pain subscale (9 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.

  5. Self-reported foot pain

    Time frame: Baseline, 3 Months

    Foot pain will be measured at baseline and at 3-months by the Pain subscale (7 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.

  6. External knee adduction moment impulse

    Time frame: Baseline, 3 Months

    The external knee adduction moment impulse will be calculated. Participants will walk on an instrumented walkway (embedded force platform(s)) while high speed cameras track the trajectories of markers placed on bony landmarks. Moments will be calculated using an inverse dynamics approach.

Secondary outcomes

  1. Self-reported overall physical function

    Time frame: Baseline, 3 Months

    Physical function will be measured by the Function, Daily Living subscale (17 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.

  2. Self-reported foot function

    Time frame: Baseline, 3 Months

    Foot function will be measured at baseline and at 3-months by the Activity Limitations subscale (3 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.

  3. External knee flexion moment impulse

    Time frame: Baseline, 3 Months

    The external knee flexion moment impulse will be calculated using the same methods as described for the external knee adduction moment impulse.

  4. Self-selected gait speed

    Time frame: Baseline, 3 Months

    Self-selected gait speed will be calculated during the biomechanical gait analyses.

  5. Rearfoot eversion peak

    Time frame: Baseline, 3 Months

    Participants will walk on an instrumented walkway while high speed cameras track the trajectories of markers placed on bony landmarks.

Other outcomes

  1. Exit Interview

    Time frame: 3 months

    Participants will be invited to take part in semi-structured interviews, and asked about their knee and pain, their experiences with their insoles, and their attitudes towards different treatment approaches to manage knee OA. The purpose of this exploratory component will be to identify any themes related to the approach and design of the study that would need to be modified for the definitive RCT. Semi-structured interviews will be conducted to explore participants' attitudes and feelings about the interventions and the study design. The conversations will be recorded digitally, transcribed verbatim, and analyzed using a framework analysis. Themes will be developed, discussed, adjusted, and grouped in an iterative and inductive process. All data will be coded according to the final thematic index generated.

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha Krowchuk

CONTACT

[email protected]

604-822-7948

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Dalhousie University
  • Western University

Registry information

Official study title

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

Acronym: MULTIWEDGE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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