Clinical trial NCT06251167: A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
Official title: A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Orthotics
Foot pain
Biomechanics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Western University
name: Dalhousie University
First posted: 2024-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a two-arm, parallel group, multi-centre randomized controlled pilot study to assess the feasibility of our unique clinical biomechanics study, as well as the preliminary efficacy of the interventions on clinical and biomechanical outcomes at the feet and knees.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recruitment - number of screened patients who are eligible
timeFrame: from onset of recruitment through study completion
measure: Retention - proportion of assessments with complete outcome measures data
timeFrame: immediately after the intervention
measure: Insoles Delivery
timeFrame: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months
measure: Self-reported knee pain
timeFrame: Baseline, 3 Months
measure: Self-reported foot pain
timeFrame: Baseline, 3 Months
measure: External knee adduction moment impulse
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: Self-reported overall physical function
timeFrame: Baseline, 3 Months
measure: Self-reported foot function
timeFrame: Baseline, 3 Months
measure: External knee flexion moment impulse
timeFrame: Baseline, 3 Months
measure: Self-selected gait speed
timeFrame: Baseline, 3 Months
measure: Rearfoot eversion peak
timeFrame: Baseline, 3 Months
Other outcomes:
measure: Exit Interview
timeFrame: 3 months
Locations:
city: Vancouver
country: Canada
facility: Motion Analysis and Biofeedback Laboratory
state: British Columbia
Study officials:
References: