Shoe Insoles for Knee Osteoarthritis

(MULTIWEDGE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of British Columbia

Must not be taking: Corticosteroids

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

No Placebo Group

Trial Summary

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.

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Motion Analysis and Biofeedback Laboratory Vancouver, Canada

Who Is Running the Clinical Trial?

University of British Columbia Lead Sponsor

Western University Collaborator

Dalhousie University Collaborator

References

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

A systematic review investigating the efficacy of laterally wedged insoles for medial knee osteoarthritis. [2022] A conservative management strategy for knee osteoarthritis is the lateral wedge insole (LWI). The theoretical basis for this intervention is to correct tibiofemoral malalignment, thereby reducing pain and optimising function. This systematic review evaluates the evidence on the effectiveness and safety of LWI for the treatment for knee osteoarthritis. A systematic review was performed, searching published (MEDLINE, AMED, EMBASE, CINAHL, Cochrane Library) and unpublished literature from their inception to August 2012. Randomised controlled trials (RCTs) were included that compared the use of LWI with a neutral insole or control intervention for people with medial compartment osteoarthritis. Risk of bias and clinical relevance were assessed, and outcomes were analysed through meta-analysis. From a total of 3,105 citations, 10 studies adhered to the a priori eligibility criteria. These included 1,095 people; 535 participants were allocated to receive LWI insoles compared to 509 in control groups. Eight per cent of papers were of high quality with low risk of bias. There was no statistically significant difference between LWI and neutral insoles for pain, function, analgesic requirement, compliance or complications (p ≥ 0.07). Those who received LWI demonstrated lower non-steroidal anti-inflammatory drug requirements (p

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] 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 knee osteoarthritis (OA) compared with an appropriate control.

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

Effect of lateral wedged insoles on the knee internal contact forces in medial knee osteoarthritis. [2019] Lateral wedge insoles (LWIs) are non-surgical interventions used in medial knee osteoarthritis (KOA) aiming at restoring correct joint biomechanics. However, the mechanical efficacy of LWIs, based on modulation of the external knee adduction moment, is partially proved and high variability in response to these devices was observed.

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

Effects of lateral wedge insole application on medial compartment knee osteoarthritis severity evaluated by ultrasound. [2018] It is known that a lateral wedge insole (LWI) decreases medial loading stress in the knee. Medial meniscus pathology, such as a degenerative tear or a root tear, leading to malfunction and medial meniscus extrusion (MME), is a critical condition that leads to severe osteoarthritis (OA). However, the effect of LWI on MME is still unknown. The objective of this study was to investigate the effect of LWI use on MME in knee OA using ultrasonography.

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

Changes in the Kinematics of Midfoot and Rearfoot Joints with the Use of Lateral Wedge Insoles. [2023] The lateral wedge insole (LWI) is a typical orthopedic treatment for medial knee osteoarthritis pain, chronic ankle instability, and peroneal tendon disorders. It is still unknown what the effects are in the most important joints of the foot when using LWIs as a treatment for knee and ankle pathologies. Objectives: The aim of this study was to determine the influence of LWIs on the position of the midfoot and rearfoot joints by measuring the changes using a tracking device. Methods: The study was carried out with a total of 69 subjects. Movement measurements for the midfoot were made on the navicular bone, and for the rearfoot on the calcaneus bone. The Polhemus system was used, with two motion sensors fixed to each bone. Subjects were compared by having them use LWIs versus being barefoot. Results: There were statistically significant differences in the varus movement when wearing a 4 mm LWI (1.23 ± 2.08°, p

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] Using the lateral wedge insole is a conservative management strategy for knee osteoarthritis. The theoretical basis for this intervention is to correct femorotibial angle, thereby reducing pain and optimising function.