A Multi-centre Feasibility Study Assessing Shoe-worn Insoles to Improve Clinical and Biomechanical Features of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Recruitment - number of screened patients who are eligible
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be aware that there will be different types of insole interventions for this study, but will not be aware of the exact details of the insoles.
Given that biomechanical assessment will be conducted in the intervention insole, it is not possible to mask the outcome assessor to intervention arm for participants. Instead, an investigator not involved in data collection will process all biomechanical data without knowledge of the intervention for a given participant.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lateral wedge insoles (LWIs)
The LWIs will incorporate a 6 degree wedge along the lateral edge of the insole.
干预措施: Lateral wedge insoles (LWIs) (Device)
Lateral wedge plus custom arch support (LWAS)
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.
干预措施: Lateral wedge plus custom arch support (LWAS) (Device)
结局指标
主要结局
Recruitment - number of screened patients who are eligible
时间窗: from onset of recruitment through study completion
The number of screened patients determined eligible to be enrolled in the study.
Retention - proportion of assessments with complete outcome measures data
时间窗: immediately after the intervention
Proportion of assessments with complete outcome measures data out of total number of assessments in the study protocol.
Self-reported foot pain
时间窗: Baseline, 3 Months
Foot pain will be measured at baseline and at 3-months by the Pain subscale (7 items) of the Foot Function Index revised short form (FFI-RS). This is a self-report questionnaire consisting of 34 items that provides the ability to quantify aspects of foot pain, disability and activity limitation.
External knee adduction moment impulse
时间窗: Baseline, 3 Months
The external knee adduction moment impulse will be calculated. Participants will walk on an instrumented walkway (embedded force platform(s)) while high speed cameras track the trajectories of markers placed on bony landmarks. Moments will be calculated using an inverse dynamics approach.
Insoles Delivery
时间窗: from date of insoles ordering until date of delivery to the laboratory, assessed up to 3 months
Time between foot scan assessment and delivery of insoles. Given that insoles will be manufactured centrally and distributed to the sites, we are interested in assessing the expected timeframe for enrollment in the study.
Self-reported knee pain
时间窗: Baseline, 3 Months
Knee pain will be measured by the Pain subscale (9 items) of the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and at 3-months. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
次要结局
- External knee flexion moment impulse(Baseline, 3 Months)
- Rearfoot eversion peak(Baseline, 3 Months)
- Self-selected gait speed(Baseline, 3 Months)
- Self-reported foot function(Baseline, 3 Months)
- Self-reported overall physical function(Baseline, 3 Months)
研究者
Michael Hunt
Professor
University of British Columbia