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New treatment option for Knee Osteoarthritis
Official title A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06251167
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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 =...
- pain in the same foot/feet as the painful knee(s)
- ability to communicate in English
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.