Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.
详细描述
A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
- •with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment
排除标准
- •with a history of previous knee surgery with an implant
- •reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
- •pregnant or planning to become pregnant
- •self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function
结局指标
主要结局
pain
时间窗: change from baseline at one month and three months after modified shoe insoles wearing
Visual analog scale, pain pressure threshold
次要结局
- Physical functional ability(change from baseline at one month and three months after modified shoe insoles wearing)
- psychological function(change from baseline at one month and three months after modified shoe insoles wearing)
- functional performance(change from baseline at one month and three months after modified shoe insoles wearing)
- quality of life(change from baseline at one month and three months after modified shoe insoles wearing)
- balance performance(change from baseline at one month and three months after modified shoe insoles wearing)
- physical activity(change from baseline at one month and three months after modified shoe insoles wearing)
研究者
Ru-Lan Hsieh
MD, Associate professor
Taipei Medical University
