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

ConditionKnee Osteoarthritis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorUniversity of British Columbia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

31 Participants

are divided into 2 treatment groups

Group A: Lateral wedge insoles (LWIs)Experimental treatment 1 intervention

Group B: Lateral wedge plus custom arch support (LWAS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Recruitment - number of screened patients who are eligible

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

Time frame

from onset of recruitment through study completion

Retention - proportion of assessments with complete outcome measures data

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

Time frame

immediately after the intervention

Insoles Delivery

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.

Time frame

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

Self-reported knee pain

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%.

Time frame

Baseline, 3 Months

Secondary outcomes

Self-reported overall physical function

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%.

Time frame

Baseline, 3 Months

Self-reported foot function

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.

Time frame

Baseline, 3 Months

External knee flexion moment impulse

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

Time frame

Baseline, 3 Months

Self-selected gait speed

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

Time frame

Baseline, 3 Months

Other outcomes

Exit Interview

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.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Western University

Collaborator

Dalhousie University

Collaborator

Source ClinicalTrials.gov

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