ClinicalTrials.gg
RecruitingNCT07932821Updated Nov 12, 2026

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

An interventional study of Electrical Muscle Stimulation and Standard Physiotherapy in Muscular Atrophy, Muscle Weakness and Muscle Weakness or Atrophy, sponsored by MSK Doctors & Associates Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by MSK Doctors & Associates Ltd · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 52 studies in Muscular Atrophy with a site in United Kingdom — 7 open to participants now, 11 under way, 2 of them phase 3. Muscular Atrophy · United Kingdom.

Planned enrollment
11th of 42
60 · median 30
Started
2026
with 2 others
No phase
30 of 52
6 open now
Primary completion
2028-06
later than 7 of 10 live
Registered
52nd of 52
by date

Among the 52 studies in Muscular Atrophy with a site in United Kingdom, this one is the 11th largest by planned enrollment of the 42 interventional ones that give a count, is one of 3 that started in 2026, is one of 30 with no phase, reaches primary completion later than 7 of the 10 other live ones, and was the 52nd registered.

Muscular Atrophy

412 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.

Browse Muscular Atrophy studies →

Open to participants now

7 of the 52 studies in Muscular Atrophy with a site in United Kingdom are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 51 Muscular Atrophy studies recruiting now, 24 (47%) set no upper age limit and 13 (25%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Muscular Atrophy
  • Muscle Weakness
  • Muscle Weakness or Atrophy

Keywords

  • Electrical Muscle Stimulation
  • Post-operative rehabilitation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 and attend all follow-up visits, including the six-week MRI assessment.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceElectrical 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.

    Also known as: Regen EMS

  • OtherStandard 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.

06

What researchers measure

Primary outcomes

  1. Percentage Change in Quadriceps Muscle Volume in the Operated Leg

    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.

    Time frame: Baseline (within 30 days before surgery) and 6 weeks after surgery.

07

Study locations

1 of 1 sites recruiting
  • MSK House
    Sleaford, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

Of 174 interventional studies with no phase under Muscular Atrophy, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartEst.
Dec 2026
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932821
Lead sponsor
MSK Doctors & Associates Ltd
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Mel Coleman
Contact
research@mskdoctors.com
+44 330 001 0048

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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