A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Lateral wedge plus custom arch support (LWAS)Device: Lateral wedge insoles (LWIs)
- Registration Number
- NCT06251167
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lateral wedge plus custom arch support (LWAS) 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. Lateral wedge insoles (LWIs) Lateral wedge insoles (LWIs) The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole.
- Primary Outcome Measures
Name Time Method Recruitment - number of screened patients who are eligible from onset of recruitment through study completion The number of screened patients determined eligible to be enrolled in the study.
Retention - proportion of assessments with complete outcome measures data immediately after the intervention Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol.
Self-reported foot pain 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.
External knee adduction moment impulse 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.
Insoles Delivery 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.
Self-reported knee pain 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%.
- Secondary Outcome Measures
Name Time Method External knee flexion moment impulse 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.
Rearfoot eversion peak Baseline, 3 Months Participants will walk on an instrumented walkway while high speed cameras track the trajectories of markers placed on bony landmarks.
Self-selected gait speed Baseline, 3 Months Self-selected gait speed will be calculated during the biomechanical gait analyses.
Self-reported foot function 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.
Self-reported overall physical function 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%.
Trial Locations
- Locations (1)
Motion Analysis and Biofeedback Laboratory
🇨🇦Vancouver, British Columbia, Canada