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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special shoe insoles can alleviate knee pain from osteoarthritis and foot pain. Two types of insoles are being tested: one with a wedge on the side (lateral wedge insoles, LWIs) and another with both a wedge and extra arch support (lateral wedge plus custom arch support, LWAS). The study will evaluate how each insole affects knee and foot pain. It is suitable for individuals who have experienced knee pain for more than six months and also have foot pain on the same side. As an unphased trial, this study provides a unique opportunity to explore new solutions for managing knee and foot pain.

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 prior data suggests that these insoles are safe for knee osteoarthritis?

Research shows that lateral wedge insoles (LWIs) are generally safe for people with knee osteoarthritis. One study found they can reduce pain in some patients, especially when carefully selected. However, another source suggests they might not suit everyone with knee osteoarthritis. No strong evidence indicates these insoles cause harm, but they might not be effective for all.

For lateral wedge insoles with custom arch support (LWAS), studies suggest they might improve symptoms in the feet and knees for some people with knee osteoarthritis. One study found that adding custom arch support to the insoles can be more helpful than using standard insoles alone. These insoles also appear safe, with no significant reports of negative effects.

Overall, both types of insoles seem well-tolerated, with no strong evidence of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these shoe insoles because they offer a new way to manage knee osteoarthritis without drugs or surgery. Unlike standard treatments like pain relievers and physical therapy, lateral wedge insoles (LWIs) and lateral wedge plus custom arch support (LWAS) insoles work by redistributing weight away from the affected area of the knee. The LWIs use a 6-degree wedge to shift pressure, while the LWAS insoles take it a step further by adding custom arch support, potentially providing even more relief. This approach could offer a non-invasive, easy-to-use option for those seeking relief from knee pain.

What evidence suggests that this trial's insoles could be effective for knee osteoarthritis?

Research has shown that special shoe inserts called lateral wedge insoles (LWIs), which participants in this trial may receive, can help reduce knee pain for people with knee osteoarthritis. One study found that these insoles reduced knee pain more than regular insoles, though the difference was small. However, some reviews suggest that LWIs alone might not always be enough to relieve knee pain.

Another treatment option in this trial is the combination of lateral wedge insoles with custom arch support (LWAS). Studies have shown encouraging results for this combination. Adding custom arch support to the wedge insoles may help with both foot and knee symptoms. This combination can lessen the pressure on the knee, which might help reduce pain and improve movement for people with knee osteoarthritis. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

I showed improvement with the insoles during a test.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30615299/

The Efficacy of a Lateral Wedge Insole for Painful Medial Knee ... Lateral wedge insoles produced a greater reduction in knee pain than neutral insoles (mean difference of 0.7 on 0-10 scale [95% confidence interval 0.1, 1.2]) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05104008

Effectiveness of Lateral Wedge Insole on Knee ... Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population. ClinicalTrials.gov ID NCT05104008.

3. nature.com nature.com/articles/s41598-023-50693-1

Biomechanical response of lower limb joints to lateral ... Relevant studies showed that LWI could reduce the peak external KAM by about 5% on the treated side, but they were not necessarily effective in ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2017/06160/a_systematic_review_and_meta_analysis_into_the.39.aspx

A systematic review and meta-analysis into the effect of... The aim of this study was to evaluate the immediate effects of lateral wedge arch support insoles (LWAS) on reducing the knee joint load in patients with medial ...

5. sogacot.org sogacot.org/articulos/ineffectiveness-of-lateral-wedge-insoles-on-the-improvement-of-pain-and-function-for-medial-knee-osteoarthritis-a-meta-analysis-of-controlled-randomized-trials/

Ineffectiveness of lateral-wedge insoles on the ... Based on the pooled results of the current meta-analysis, lateral-wedge insoles as an independent treatment appeared to be ineffective in attenuating knee pain ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3100910/

Lateral wedge insoles for medial knee osteoarthritis In summary, our findings showed that lateral wedge insoles had no effect on symptoms or disease progression over 12 months in people with mild to moderate ...

7. oarsijournal.com oarsijournal.com/article/S1063-4584(18)30151-1/fulltext

The efficacy of lateral wedge insoles for painful medial ... We found that lateral wedge insoles were effective in reducing pain in medial OA patients, especially if patients are prescreened to select those likely to ...

8. aaos.org aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/oak3cpg.pdf

Management of Osteoarthritis of the Knee (Non-Arthroplasty) Lateral wedge insoles are not recommended for patients with knee osteoarthritis. Strength of Recommendation: Strong. Evidence from two or more “ ...

9. mdpi.com mdpi.com/1424-8220/23/1/84

A Study on the Effects of Lateral-Wedge Insoles on Plantar ... Lateral-wedge insoles may protect against plantar pressure deterioration in patients with knee osteoarthritis.

10. journals.lww.com journals.lww.com/md-journal/fulltext/2016/07050/clinical_effects_of_lateral_wedge_arch_support.12.aspx

Clinical effects of lateral wedge arch support insoles in... We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), ...