Shoe Insoles for Knee Osteoarthritis

(MULTIWEDGE Trial)

Overseen By Natasha Krowchuk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Corticosteroids

Disqualifiers: Lateral OA, Knee surgery, Systemic arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used corticosteroids in the past 6 months.

What data supports the effectiveness of this treatment for knee osteoarthritis?

Research shows that lateral wedge insoles (LWIs) can help reduce the need for pain medication in people with knee osteoarthritis, although they may not significantly reduce pain or improve function compared to regular insoles. They are also known to decrease stress on the inner part of the knee, which might help manage the condition. ^{1 2 3 4 5}

Is it safe to use shoe insoles for knee osteoarthritis?

Research shows that lateral wedge insoles (LWIs) for knee osteoarthritis are generally safe, with no significant difference in complications compared to neutral insoles. They may reduce the need for pain medication, indicating a favorable safety profile. ^{1 2 3 4 5}

How is the treatment with lateral wedge insoles for knee osteoarthritis different from other treatments?

Lateral wedge insoles (LWIs) and lateral wedge plus custom arch support (LWAS) are unique non-surgical treatments for knee osteoarthritis that aim to correct joint alignment and reduce knee joint load, potentially decreasing pain and improving function. Unlike medications, these insoles work by altering the biomechanics of the knee, but their effectiveness can vary among individuals. ^{1 2 3 5 6}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people with knee osteoarthritis who've had knee pain for over 6 months, have specific changes in their knee joint seen on X-rays, and report a certain level of pain. They must also have foot pain on the same side as the affected knee and be able to communicate in English.

Inclusion Criteria

I have had knee pain for more than 6 months.

My knee pain has been at least 3 out of 10 for the last 6 months.

I showed improvement with the insoles during a test.

Exclusion Criteria

I am currently using or have recently used corticosteroids.

I have a condition that causes joint pain or swelling.

Radiographic evidence of more lateral tibiofemoral OA than medial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive shoe-worn insoles (LWAS or LWIs) to assess their effects on knee and foot pain

12 weeks

Baseline visit, 3-month follow-up visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including self-reported pain and physical function assessments

4 weeks

Exit interview

Treatment Details

Interventions

• Lateral wedge insoles (LWIs)
• Lateral wedge plus custom arch support (LWAS)

Trial Overview The study is testing two types of shoe-worn insoles: one with just a lateral wedge (LWIs) and another combining a lateral wedge with custom arch support (LWAS). It aims to see if these can help relieve symptoms at both the feet and knees.

Participant Groups

Group I: Lateral wedge plus custom arch support (LWAS) Experimental Treatment 1 Intervention

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.

Group II: Lateral wedge insoles (LWIs) Experimental Treatment 1 Intervention

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

Lateral wedge insoles (LWIs) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Lateral wedge insoles for:

• Knee osteoarthritis
• Foot pain associated with knee osteoarthritis

Approved in United States as Lateral wedge insoles for:

• Knee osteoarthritis
• Foot pain associated with knee osteoarthritis

Approved in Canada as Lateral wedge insoles for:

• Knee osteoarthritis
• Foot pain associated with knee osteoarthritis

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Western University

Collaborator

Trials

31

Recruited

129,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Findings from Research

A systematic review of 10 randomized controlled trials involving 1,095 participants found no significant difference in pain relief or function between lateral wedge insoles (LWI) and neutral insoles for knee osteoarthritis, suggesting limited efficacy of LWI.

However, participants using LWI required significantly fewer non-steroidal anti-inflammatory drugs (NSAIDs), indicating a potential benefit in reducing medication use, despite the overall lack of strong evidence for LWI's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review investigating the efficacy of laterally wedged insoles for medial knee osteoarthritis. Penny, P., Geere, J., Smith, TO.[2022]

Lateral wedge arch support insoles (LWAS) showed statistically significant reductions in knee joint load parameters in patients with medial knee osteoarthritis, specifically the first and second peak external knee adduction moments and knee adduction angular impulse, based on a meta-analysis of 9 studies with 356 participants.

However, the effectiveness of LWAS varied depending on the type of control used in the studies, with no significant reductions observed when compared to control shoes or flat insoles, suggesting that LWAS may not be a reliable intervention for reducing knee load in all scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis into the effect of lateral wedge arch support insoles for reducing knee joint load in patients with medial knee osteoarthritis. Xing, F., Lu, B., Kuang, MJ., et al.[2022]

In a study involving 15 adults with medial knee osteoarthritis (KOA), lateral wedge insoles (LWIs) did not significantly reduce the medial compressive force (MCF) during gait, indicating limited mechanical efficacy for this population.

There was a high variability in individual responses to LWIs, with some participants experiencing increases in MCF, suggesting that personalized approaches may be necessary to enhance the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of lateral wedged insoles on the knee internal contact forces in medial knee osteoarthritis. Mannisi, M., Dell'Isola, A., Andersen, MS., et al.[2019]

In a study involving 31 knees from 18 patients with knee osteoarthritis (OA), the use of a lateral wedge insole (LWI) significantly reduced medial meniscus extrusion (MME) when patients were standing, indicating a potential therapeutic benefit for OA management.

In contrast, the control group of 22 knees from 11 volunteers without OA showed no significant difference in MME with or without the LWI, suggesting that the insole's effects are specific to individuals with knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lateral wedge insole application on medial compartment knee osteoarthritis severity evaluated by ultrasound. Ishii, Y., Deie, M., Fujita, N., et al.[2018]

The study involving 69 subjects found that using a 4 mm lateral wedge insole (LWI) significantly altered the movement of the midfoot and rearfoot joints compared to being barefoot, indicating its potential impact on foot mechanics.

Specifically, the LWI caused increased varus and plantarflexion movements in the midfoot and valgus movements in the rearfoot, suggesting that LWIs can effectively modify joint positions in patients with knee and ankle pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the Kinematics of Midfoot and Rearfoot Joints with the Use of Lateral Wedge Insoles. Gómez Carrión, Á., Atín Arratibe, MLÁ., Morales Lozano, MR., et al.[2023]

Lateral wedge insoles can effectively improve the femorotibial angle in patients with knee osteoarthritis, as shown by a meta-analysis of 2 trials, but this change does not translate to significant pain relief or functional improvement.

The systematic review, which included 8 randomized controlled trials, found no statistically significant changes in pain scores or functional outcomes when using wedge insoles compared to flat insoles, indicating limited clinical benefit for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Wedged Insole an Effective Treatment Option When Compared with a Flat (Placebo) Insole: A Systematic Review and Meta-Analysis. Zhang, B., Yu, X., Liang, L., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A systematic review investigating the efficacy of laterally wedged insoles for medial knee osteoarthritis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis into the effect of lateral wedge arch support insoles for reducing knee joint load in patients with medial knee osteoarthritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of lateral wedged insoles on the knee internal contact forces in medial knee osteoarthritis. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of lateral wedge insole application on medial compartment knee osteoarthritis severity evaluated by ultrasound. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in the Kinematics of Midfoot and Rearfoot Joints with the Use of Lateral Wedge Insoles. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Is the Wedged Insole an Effective Treatment Option When Compared with a Flat (Placebo) Insole: A Systematic Review and Meta-Analysis. [2023]