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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
48
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Ishaq Ahmed, PhD PT
- 電話番号:03344066463
- メール:ishaq.ahmed@uipt.uol.edu.pk
研究連絡先のバックアップ
- 名前:Ashfaq Ahmed, PhD PT
- 電話番号:03009449192
- メール:ashfaq.ahmed@uipt.uol.edu.pk
研究場所
-
-
Punjab Province
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Lahore、Punjab Province、パキスタン、54000
- 募集
- University of Lahore Teaching Hospital, Lahore, Pakistan
-
コンタクト:
- Asim Arif, PhD PT*
- 電話番号:03216597727
- メール:asim.arif@uipt.uol.edu.pk
-
コンタクト:
- Mahnoor Fatima, MS MSK*
- 電話番号:03164247896
- メール:70174837@student.uol.edu.pk
-
主任研究者:
- Mahnoor Fatima, MS MSK
-
主任研究者:
- Hafiza Sana Ashraf, PhD PT*
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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
|
|
アクティブコンパレータ: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional disability:(WOMAC)
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Mahnoor Fatima, MS MSK*、University Institute of Physical Therapy, University of Lahore
- 主任研究者:Hafiza Sana Ashraf, PhD PT*、University Institute of Physical Therapy, University of Lahore
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月25日
一次修了 (推定)
2026年8月25日
研究の完了 (推定)
2026年9月10日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。