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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mel Coleman
- Número de telefone: +44 330 001 0048
- E-mail: research@mskdoctors.com
Locais de estudo
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Sleaford, Reino Unido
- Recrutamento
- MSK House
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Contato:
- Mel Coleman
- Número de telefone: +44330 001 0048
- E-mail: research@mskdoctors.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
Outros nomes:
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Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage Change in Quadriceps Muscle Volume in the Operated Leg
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
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Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- 26/WM/0063
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