A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis (NCT06251167) | Clinical Trial Compass
RecruitingNot Applicable
A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
Canada31 participantsStarted 2024-03-04
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment - number of screened patients who are eligible
Timeframe: from onset of recruitment through study completion
2
Retention - proportion of assessments with complete outcome measures data
Timeframe: immediately after the intervention
3
Insoles Delivery
Timeframe: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months