Weighted Dangling Exercises vs Vastus Medialis Oblique Muscle Neuromuscular Stimulation for Knee Osteoarthritis
2026年7月8日 更新者:Mahnoor Fatima、University of Lahore
Effectiveness of Weighted Dangling Exercises Versus Vastus Medialis Oblique Muscle Neuromuscular Stimulation in Patients With Knee Osteoarthritis
This randomized controlled trial aims to compare the effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis.
The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital using convenience sampling.
Participants will be randomly allocated into two groups: an interventional group receiving WDE and other interventional group undergoing VMO strength training with NMES.
Both interventions will be administered three times per week for 8 weeks under professional supervision.
Outcome measures including pain intensity (NPRS), Functional Disability (Western Ontario and McMaster Universities Osteoarthritis Index),Muscle Strength (MMT) will be assessed at baseline, 4 weeks, and 8 weeks.
Data will be analyzed using SPSS, with appropriate parametric or non-parametric tests applied after checking data normality.
Ethical approval will be obtained, informed consent will be secured, and participant confidentiality will be strictly maintained.
研究概览
详细说明
This study is a single-blinded randomized controlled trial designed to evaluate and compare the therapeutic effectiveness Weighted dangling exercises versus vastus medialis oblique muscle neuromuscular electrical stimulation(VMO+NMES) in patients with knee osteoarthritis.
The study will recruit 48 participants (accounting for 10% attrition), aged 40-60 years, from University of Lahore Teaching Hospital over a duration of 9 months following synopsis approval.
A total sample size of 48 participants (24 per group) has been determined using epitool software, based on theWestern Ontario and McMaster Universities Osteoarthritis Index) , with a confidence level of 95%, power of 80%, and a 10% attrition allowance.
Participants aged 40-60 years, of both genders, with clinically confirmed knee osteoarthritis.
Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion.
Radiographic Knee osteoarthritis examination.
Exclusion includes recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, or those with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded.
Eligible participants will be enrolled after providing written informed consent and randomized using a computer-generated block randomization method, with allocation concealment ensured through sealed opaque envelopes.
Outcome assessors will be blinded to group allocation to minimize assessment bias.
The one group will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down.
Other group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF.
Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions.
Primary and secondary outcome measures include pain intensity (Numeric Pain Rating Scale),theWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC), muscle strength, assessed at baseline, 4 weeks, and 8 weeks post-intervention.
Data will be analyzed using SPSS (version 25/27).
Descriptive statistics will summarize participant characteristics, while inferential statistics will be applied based on data distribution, with significance determined accordingly.
Ethical considerations will strictly adhere to the guidelines of the Institutional Research Ethics Board (IREB), University of Lahore.
Participant confidentiality, voluntary participation, right to withdraw, and safety monitoring will be ensured throughout the study.
No serious adverse effects are anticipated.
研究类型
介入性
注册 (估计的)
48
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Ishaq Ahmed, PhD PT
- 电话号码:03344066463
- 邮箱:ishaq.ahmed@uipt.uol.edu.pk
研究联系人备份
- 姓名:Ashfaq Ahmed, PhD PT
- 电话号码:03009449192
- 邮箱:ashfaq.ahmed@uipt.uol.edu.pk
学习地点
-
-
Punjab Province
-
Lahore、Punjab Province、巴基斯坦、54000
- 招聘中
- University of Lahore Teaching Hospital, Lahore, Pakistan
-
接触:
- Asim Arif, PhD PT*
- 电话号码:03216597727
- 邮箱:asim.arif@uipt.uol.edu.pk
-
接触:
- Mahnoor Fatima, MS MSK*
- 电话号码:03164247896
- 邮箱:70174837@student.uol.edu.pk
-
首席研究员:
- Mahnoor Fatima, MS MSK
-
首席研究员:
- Hafiza Sana Ashraf, PhD PT*
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
Both genders and aged between 40 and 60 years. Symptoms of unilateral knee pain and crepitus persist for at least 6 months during ascending and descending motion. Radiographic KOA; grade 2 or more according to Kellgren and Lawrence scale. Patient referred by an orthopedic physician Those who have taken oral corticosteroids within the last month or who received intra-articular corticosteroid injection or analgesic injection intervention for hip or knee pain within the last 3 month
Exclusion Criteria:
- Recent surgery (within three months) history of hip or knee joint replacement, tibial osteotomy, orthoses with systemic arthritis, history of trauma such as knee fracture and other with muscular disease of neurological disorders that would affect lower extremity function is excluded.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:interventional group A
The experimental group A will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
|
This group receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
|
|
有源比较器:interventional group B
Experimental group B receive neuromuscular electrical stimulation (NMES) specifically targeting the vastus medialis oblique (VMO).
The NMES parameters are as follows: electrodes were placed above the superomedial border of the patella, oriented at a 55° angle to the vertical.
The stimulation frequency set at 50 Hz, with a pulse duration of 250 µs and a duty cycle of 10 seconds ON and 30 seconds OFF
|
The one group will receive weighted dangling exercise.
A gravity-assisted flexion-extension movements of the lower legs Ankle cuffs weight worn during the exercise while seated on a high couch with their legs hanging down
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
大体时间:baseline,4 weeks and 8 weeks
|
Pain in this study is defined as subjective discomfort in the knee joint caused by osteoarthritis.
It was evaluated using the Numeric Pain Rating Scale (NPRS), which is a reliable and proven technique for quantifying pain intensity.
Participants score their discomfort on an 11-point scale, with 0 indicating "no pain" and 10 representing "the worst pain imaginable.
|
baseline,4 weeks and 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional disability:(WOMAC)
大体时间:Baseline 4 weeks and 8 weeks
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a well-used and validated questionnaire.
The WOMAC measures three dimensions: pain (5 things), stiffness (2 items), and physical function (17 items).
Each item is assessed on a scale of 0 (no difficulty) to 4 (severe difficulty), with a total WOMAC score of 0-96.
Higher scores indicate greater functional disability.
The questionnaire examines pain while walking or ascending stairs, stiffness in the morning or later in the day, and difficulty with sitting, standing, and lifting objects.
|
Baseline 4 weeks and 8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Mahnoor Fatima, MS MSK*、University Institute of Physical Therapy, University of Lahore
- 首席研究员:Hafiza Sana Ashraf, PhD PT*、University Institute of Physical Therapy, University of Lahore
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月25日
初级完成 (估计的)
2026年8月25日
研究完成 (估计的)
2026年9月10日
研究注册日期
首次提交
2026年7月8日
首先提交符合 QC 标准的
2026年7月8日
首次发布 (实际的)
2026年7月14日
研究记录更新
最后更新发布 (实际的)
2026年7月14日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.