Using shoe insoles to relieve knee osteoarthritis symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of shoe-worn insoles, specifically lateral wedge insoles and those with custom arch support, in providing relief for individuals suffering from knee osteoarthritis. The trial will be conducted across multiple centers and aims to assess both the feasibility and preliminary efficacy of these orthotic devices. Participants will undergo a biomechanical assessment to determine their eligibility based on their response to the insoles. The study focuses on individuals who experience knee pain and foot pain simultaneously, as both conditions may be interconnected.

Why it matters

Who can join: the full rules

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.

Where it's running

• Motion Analysis and Biofeedback Laboratory
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Natasha Krowchuk
• Email: natasha.krowchuk@ubc.ca
• Phone: 604-822-7948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.