Using shoe insoles to relieve knee osteoarthritis symptoms
A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
This study is testing if special shoe insoles can help people with knee osteoarthritis feel less pain, especially those who also have foot pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06251167 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with medial tibiofemoral osteoarthritis, experiencing knee pain for over six months, and also reporting foot pain.
Not a fit: Patients with more lateral tibiofemoral osteoarthritis or those who have had recent knee surgery or corticosteroid treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a non-invasive treatment option that alleviates knee pain and improves mobility for patients with knee osteoarthritis.
How similar studies have performed: Previous studies have shown promise in using orthotics for knee osteoarthritis, but this specific approach is being evaluated for the first time in a multi-centre setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.