Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
This randomized-controlled trial aims to investigate the effect of NMES as an add-on to an exercise program in patients with degenerative meniscus tears.
详细描述
To investigate the efficacy of NMES as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: Group 1 (NMES with Exercise) and Group 2 (Exercise). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being aged between 40 and 65 years
- •Having the degenerative meniscus tear in at least one knee
- •Having body mass index in the range of 18-30 kg/m2
- •Feeling the pain that lasts for at least 2 months
- •Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results
- •Having the ability to read and write Turkish
排除标准
- •Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear
- •Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks
- •Have received steroid injections in the last 6 months
- •Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis
- •Presence of any systemic disorder that may affect assessment parameters
- •Failure to cooperate with assessments
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline
Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
次要结局
- Muscle Strength(At the end of the 8-week intervention)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(At the end of 8-week intervention)
- Lysholm Score(At the end of the 8-week intervention)
- Short Form-12 (SF-12)(At the end of the 8-week intervention)
- Visual Analogue Scale (VAS)(At the end of 8-week intervention)
- Active Range of Motion(At the end of 8-week intervention)
研究者
Tansu Birinci
Principal Investigator
Istanbul University - Cerrahpasa