Effect of a Lateral Wedge Insole and Simple Knee Sleeve as a Single and Combined Treatment on Biomechanical and Clinical Outcomes in Individuals With Knee Osteoarthritis (The IN-SLEEVE Study).
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- External knee adduction moment (EKAM)
研究概览
简要总结
The focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the short term effect over 6 weeks. Secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3 out of 10) because our aim of the study to reduce pain with combined treatment and pain lower than 3 out of 10 score might not allow to compared the pain reduction between the group.
- •2- Definitive medial joint narrowing higher or equal to the lateral side and osteophytes on X-Ray A-P or PA view in weight bearing position if possible.
- •3- Medial joint tenderness either by patient's indication or the clinician under the clinical examination indicating tenderness in the tibiofemoral joint.
- •4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological plain x-ray will be used.
- •5- Being able to walk without assisted devices for 100 meters non-stop because he or she will not be able to complete this study protocol.
排除标准
- •1- More pain localized to patellpfemoral or lateral joint than the medial knee side on examination.
- •2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any other realignment operation. 6- Total knee replacement. 7- Any condition contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected intra-articular knee joint space in the previous month.
- •9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher will be excluded because previous study showed that individuals with 33 BMI.
- •11- Lower than 35 years and higher than 85 as this period was identified to highest incidence period (Losina et al., 2013). Although individuals with 86 and higher has high prevalence to the knee OA, exclusion this population was important due to high amount of walking and balance test.
结局指标
主要结局
External knee adduction moment (EKAM)
时间窗: 6 weeks
External knee adduction moment is a curve which is consider as indirect measurement of the knee loading. Using the gait analysis system will give us this outcome
Muscle co-contraction
时间窗: 6 weeks
Muscle co-contraction can be measured after using Electromyography machine. This outcome gives us indicator to the effect of the treatment on muscle activity and loading.
Dynamic balance
时间窗: 6 weeks
The modified star excursion balance test will be used. In this test, the participants balance on maintaining single-leg stance, while reaching with the free limb in anterior and lateral directions in relation to the stance foot as far as they can, then return to double support without losing balance.
Pain measurment.
时间窗: 6 weeks
10 cm visual analogue scale will be used to measure pain.
次要结局
- Pressure pain threshold(6 weeks)
- Joint position sense(6 weeks)
- Physical activity level(6 weeks)
- Physical function tests(6 weeks)
研究者
Omar waslallah althomali
Omar Althomali, PhD student, Principal Investigator, University of Salford
University of Salford