A Multi-centre Study of Shoe-worn Insoles and Knee Osteoarthritis (MULTIWEDGE)

University of British Columbia

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Lateral wedge plus custom arch support (LWAS); Device: Lateral wedge insoles (LWIs)

Study type: Interventional

Funder types: Other

Identifiers

NCT06251167

H22-03584

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 2 patient groups

Lateral wedge insoles (LWIs)

Experimental group

Description:

The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole.

Treatment:

Device: Lateral wedge insoles (LWIs)

Lateral wedge plus custom arch support (LWAS)

Experimental group

Description:

The LWAS insoles will incorporate custom arch support along the medial edge as well as a 6 degree wedge along the lateral edge of the insole.

Treatment:

Device: Lateral wedge plus custom arch support (LWAS)