Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in knee joint load during walking: knee adduction moment
研究概览
简要总结
Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. One such treatment is the use of orthotics to reduce pain and increase function in people with knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and contradictory, and could benefit from more research taking into account foot posture. This study aims to compare the use of two orthotics designs in people with knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- •ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
- •iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
排除标准
- •i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
- •ii) knee surgery or intra-articular corticosteroid injection within the previous six months
- •iii) current or recent (within 4 weeks) oral corticosteroid use
- •iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months
- •v) ankle/foot pathology or pain that precludes the use of orthotics
- •vi) current use of foot orthotics
- •vii) use of footwear unable to accommodate an orthotic
- •viii) unable to walk without a gait aid
- •ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
研究组 & 干预措施
Lateral wedge plus medial arch support
The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance.
干预措施: Lateral wedge plus medial arch support (Device)
Lateral wedge
The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance.
干预措施: Lateral wedge (Device)
结局指标
主要结局
Change in knee joint load during walking: knee adduction moment
时间窗: Baseline and 2 months
Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected. The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.
Change in Knee Pain
时间窗: Baseline and 2 Months
The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
次要结局
- Change in Self-Reported Physical Function(Baseline and 2 Months)
- Change in Foot Pain(Baseline and 2 Months)