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

Официальное название

A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis

Обзор

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.

Вмешательства

• Устройство Lateral wedge insoles (LWIs)
  Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. The LWIs will be constructed via 3D printing using a material of uniform density made to the length of the participant's feet, and will incorporate a 6 degree wedge along the lateral edge.
• Устройство Lateral wedge plus custom arch support (LWAS)
  Participants will be asked to wear these insoles in their own shoes for at least 5 hours per day for a period of 3 months. These insoles will be designed based on an innovative tablet-based app designed by industry partner Kintec Footlabs, who will be the provider of the insoles for this project. Using the high-fidelity 3D scanning tool available (Apple's True Depth sensor), the Epitek Self-Scanner app captures tens of thousands of 3D data points within a single 1-second capture, and then upload

Первичные конечные точки

• Recruitment - number of screened patients who are eligible [Срок оценки: from onset of recruitment through study completion]
• Retention - proportion of assessments with complete outcome measures data [Срок оценки: immediately after the intervention]
• Insoles Delivery [Срок оценки: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months]
• Self-reported knee pain [Срок оценки: Baseline, 3 Months]
• Self-reported foot pain [Срок оценки: Baseline, 3 Months]
• External knee adduction moment impulse [Срок оценки: Baseline, 3 Months]

Вторичные конечные точки (5)

• Self-reported overall physical function [Срок оценки: Baseline, 3 Months]
• Self-reported foot function [Срок оценки: Baseline, 3 Months]
• External knee flexion moment impulse [Срок оценки: Baseline, 3 Months]
• Self-selected gait speed [Срок оценки: Baseline, 3 Months]
• Rearfoot eversion peak [Срок оценки: Baseline, 3 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Motion Analysis and Biofeedback Laboratory — Vancouver

Идентификаторы

NCT: NCT06251167 · H22-03584

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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