Electrical Muscle Stimulation (EMS) Versus Standard Physiotherapy for Quadriceps Recovery Following Total Knee Replacement
A Prospective Controlled Study Comparing Electrical Muscle Stimulation (EMS) Versus Standard Physiotherapy for Post-Operative Quadriceps Recovery Following Total Knee Replacement Surgery
This study will investigate whether adding electrical muscle stimulation (EMS) to standard physiotherapy helps preserve thigh muscle and improve recovery after knee surgery.
Pain, swelling and reduced activity after surgery can make it difficult to activate the quadriceps muscles at the front of the thigh. These muscles straighten the knee and support everyday activities such as standing, walking and climbing stairs. Muscle weakness and loss of muscle volume can delay rehabilitation. EMS delivers small electrical pulses through pads placed on the skin to make these muscles contract. It may therefore support muscle activation during recovery, when voluntary exercise can be difficult.
This prospective, randomised, controlled clinical trial will be conducted at one centre. The planned sample is 60 adults aged 18 years or older undergoing elective surgery on one knee. Participants will provide written informed consent before joining the study. After surgery, they will be assigned by chance to one of two groups, with 30 participants in each group.
All participants will receive standard physiotherapy and routine post-operative care. The intervention group will also use a portable Regen EMS device at home. Participants will receive training in operating the device and positioning the pads on the thigh, approximately 20 cm above the surgical wound. They will be asked to complete five 10-minute sessions each day. The comparison group will receive standard physiotherapy alone.
The primary outcome is the percentage change in quadriceps muscle volume in the operated leg, measured using magnetic resonance imaging (MRI) before surgery and six weeks afterwards. Researchers will compare the average percentage change between the two groups to assess whether adding EMS helps preserve muscle volume.
The study will also assess knee function using the Oxford Knee Score and Knee Society Score, alongside pain and satisfaction with recovery. These assessments will help establish whether changes in muscle volume are accompanied by differences in symptoms and function.
The research team will monitor EMS use, complications and any unwanted effects, including skin irritation or discomfort. EMS treatment may be adjusted, paused or stopped if necessary, while participants continue to receive appropriate standard care.
The findings will provide preliminary evidence about the effects of EMS on muscle preservation and early recovery after knee surgery, and help inform the design and sample size of a larger clinical trial.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mel Coleman
- 電話番号：+44 330 001 0048
- メール：research@mskdoctors.com
研究場所
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Sleaford、イギリス
- 募集
- MSK House
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コンタクト：
- Mel Coleman
- 電話番号：+44330 001 0048
- メール：research@mskdoctors.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 18 years or older undergoing elective unilateral knee surgery, such as cartilage or meniscal repair, anterior cruciate ligament reconstruction, or arthroplasty.
- Able to undergo magnetic resonance imaging (MRI), with no contraindications to MRI.
- Pre-operative baseline MRI completed within 30 days before surgery.
- Willing and able to comply with the assigned rehabilitation programme and, if allocated to the EMS group, the prescribed electrical muscle stimulation regimen.
- Able to provide written informed consent and attend all follow-up visits, including the six-week MRI assessment.
Exclusion Criteria:
- Contraindications to MRI, including non-MRI-safe implants or severe claustrophobia that cannot be managed.
- Diagnostic knee arthroscopy, including procedures involving only limited intervention, such as washout, debridement or loose body removal.
- An implanted pacemaker or defibrillator, other active electrical implants, programmable shunts or deep brain stimulators.
- Active skin disease, open wounds or dermatitis at the intended EMS electrode sites, or impaired sensation over the thigh.
- Active infection, fever or post-operative wound breakdown.
- Known epilepsy or seizure disorder.
- Significant neuromuscular disorders affecting the quadriceps, such as peripheral neuropathy or myopathy, or previous major surgery to the quadriceps on the operated side.
- Acute deep vein thrombosis or pulmonary embolism within the preceding three months, severe peripheral vascular disease or uncontrolled cardiac disease.
- Pregnancy or breastfeeding.
- Any condition that, in the investigator's judgement, would interfere with adherence to the protocol or assessment of study outcomes.
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Electrical Muscle Stimulation Plus Standard Physiotherapy
Participants receive standard post-operative physiotherapy plus electrical muscle stimulation using the Regen EMS device following knee surgery. Participants are trained to use the device at home, with pads positioned on the thigh approximately 20 cm above the surgical wound. EMS is administered five times daily for 10 minutes per session. Participants continue to receive routine post-operative care. |
Electrical muscle stimulation is delivered to the quadriceps using a portable Regen EMS device alongside standard post-operative physiotherapy. Participants receive training in home use, with electrode pads positioned on the thigh approximately 20 cm above the surgical wound. Participants complete five 10-minute sessions daily using the manufacturer's recommended parameters and record their device use. Treatment may be adjusted, paused or stopped if discomfort or skin irritation occurs.
他の名前：
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アクティブコンパレータ：Standard Physiotherapy Alone
Participants receive standard post-operative physiotherapy and routine care following knee surgery, as recommended by their treating surgeon and physiotherapy team. Participants in this group do not receive electrical muscle stimulation. |
Standard post-operative physiotherapy following knee surgery, provided according to the rehabilitation recommendations of the treating surgeon and physiotherapy team. Participants in both study groups receive standard physiotherapy as part of their routine post-operative care. |
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 |
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Percentage Change in Quadriceps Muscle Volume in the Operated Leg
時間枠：Baseline (within 30 days before surgery) and 6 weeks after surgery.
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Quadriceps muscle volume in the operated leg is measured using magnetic resonance imaging (MRI) before surgery and six weeks after surgery. Percentage change is calculated for each participant as: [(six-week muscle volume minus baseline muscle volume) / baseline muscle volume] × 100. The mean percentage change is compared between participants receiving electrical muscle stimulation plus standard physiotherapy and those receiving standard physiotherapy alone. Positive values indicate increased muscle volume; negative values indicate muscle volume loss. |
Baseline (within 30 days before surgery) and 6 weeks after surgery.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26/WM/0063
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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