Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Knee pain via a visual analogue scale
研究概览
简要总结
It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.
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, Outcomes Assessor)
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
- •Eligibility will be confirmed by radiographic and clinical examination
- •People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking >3 on an 11-point scale
- •varus knee malalignment on standing anteroposterior lower limb x-ray.
排除标准
- •advanced radiographic knee OA (Kellgren and Lawrence stage 4
- •knee surgery or intra-articular corticosteroid injection within 6 months
- •current or past (within 4 weeks) oral corticosteroid use
- •systemic arthritic conditions
- •history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
- •any other muscular, joint or neurological condition affecting lower limb function
- •ankle/foot pathology or pain that precludes the use of insoles
- •use of foot orthotics within past 6 months and
- •use of footwear that does not accomodate an insole.
研究组 & 干预措施
Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
干预措施: Laterally wedged shoe insoles (Device)
Flat control insoles
干预措施: Control insole group (Device)
结局指标
主要结局
Knee pain via a visual analogue scale
时间窗: Measured at baseline and 12 months
Disease progression via MRI measurements of knee cartilage volume
时间窗: Measured at baseline and 12 months
次要结局
- Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index(Measured at baseline and 12 months)
- Patient perceived response to treatment(Measured at baseline and 12 months.)
- Health-related quality-of-life (via SF-36, AQoL questionnaires)(Measured at baseline and 12 months)
- Recorded use of health care(Measured at baseline and 12 months)
研究者
Kim Bennell
Professor Kim Bennell
University of Melbourne