Electrical Muscle Stimulation (EMS) Versus Standard Physiotherapy for Quadriceps Recovery Following Total Knee Replacement

November 5, 2026 updated by: MSK Doctors & Associates Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Electrical Muscle Stimulation

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.

Other Names:
  • Regen EMS
Active Comparator: 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.
Other: Standard Physiotherapy

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change in Quadriceps Muscle Volume in the Operated Leg
Time Frame: Baseline (within 30 days before surgery) and 6 weeks after surgery.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MSK Doctors & Associates Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26/WM/0063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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