Neuromuscular Electrical Stimulation for Total Knee Replacement

Recruiting at 2 trial locations

Overseen By Maggie Givan, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: ICD, Active cancer, DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

3250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new rehabilitation method to improve recovery after total knee replacement. It focuses on neuromuscular electrical stimulation (NMES), which uses mild electrical pulses to strengthen thigh muscles. The goal is to determine if NMES can reduce muscle weakness and improve overall function after surgery. Ideal candidates for this trial are those who recently had a single knee replaced, began rehab within five days, and are receiving regular outpatient physical therapy. As an unphased trial, this study provides an opportunity to contribute to innovative rehabilitation research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that neuromuscular electrical stimulation is safe for patients undergoing total knee replacement?

Research has shown that neuromuscular electrical stimulation (NMES) is generally safe for individuals recovering from total knee replacement. Studies suggest that NMES can strengthen the thigh muscles and improve their function post-surgery. Although there are no major safety concerns, some individuals might experience mild skin irritation at the electrode sites. Overall, this treatment is considered safe and can aid in muscle strength and recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Neuromuscular Electrical Stimulation (NMES) for total knee replacement recovery because it offers a novel way to enhance physical function post-surgery. Unlike standard rehabilitation, which typically relies on physical therapy and exercises, NMES uses electrical impulses to stimulate muscles directly. This method can potentially accelerate recovery by improving muscle strength and function in the early postoperative period. By integrating NMES with usual care, there's a hope to significantly boost recovery outcomes and help patients regain mobility more quickly.

What evidence suggests that NMES is effective for improving quadriceps strength after knee replacement?

Research has shown that neuromuscular electrical stimulation (NMES), which participants in this trial may receive, can strengthen the quadriceps muscle after knee replacement surgery. A review of studies found that NMES not only increases muscle strength but also reduces pain and improves function post-surgery. Studies indicate that NMES can reduce the loss of quadriceps strength by 40% in the first month following surgery. Patients who used NMES experienced better mobility and quicker recovery, allowing them to stand up from a chair and walk a certain distance more easily. Significant improvements in physical function were noted at 6 and 12 weeks after surgery. These findings suggest that NMES is a promising method for improving recovery after knee replacement. ^{1 4 6 7 8}

Who Is on the Research Team?

Jennifer Stevens-Lapsley, PT, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone total knee replacement surgery and are experiencing significant muscle weakness. To participate, they should be part of the two healthcare organizations involved in the study.

Inclusion Criteria

Site Inclusion Criteria: UCHealth or Intermountain Health outpatient physical therapy clinic

I have had a knee replacement surgery on one knee.

I have attended at least 3 physical therapy sessions.

Exclusion Criteria

I do not have an ICD, active cancer, or recent DVT in my leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative assessments including Timed Up and Go, 30 Second Sit-to-Stand, and Knee Range of Motion

1 week

1 visit (in-person)

Post-operative Rehabilitation

Participants receive either NMES or usual care rehabilitation to improve physical function after TKA

24 weeks

Multiple visits (in-person) up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NMES

Trial Overview The trial is testing Neuromuscular Electrical Stimulation (NMES) versus usual post-surgery care to see if NMES can better improve muscle strength and overall function after a knee replacement.

How Is the Trial Designed?

Group I: NMES Experimental Treatment 1 Intervention

Neuromuscular Electrical Stimulation (NMES) consists of usual care rehabilitation plus evidence-based implementation of NMES in the early postoperative period to improve physical function after TKA.

Group II: Usual Care Active Control 1 Intervention

The Usual Care clinics will continue clinical practice as normal. Usual Care sites will not have overlap of personnel or training with NMES Sites.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

University of Colorado Health

Collaborator

Trials

4

Recruited

1,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Intermountain Health Care, Inc.

Collaborator

Trials

142

Recruited

1,965,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8677678/

Effect of Neuromuscular Electrical Stimulation After Total Knee ... This systematic review and meta-analysis is the first to identify that postoperative NMES could improve the quadriceps muscle strength, pain, and function ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06953375

Implementation of Neuromuscular Electrical Stimulation ... In controlled settings, NMES has established efficacy and attenuates quadriceps strength loss by 40% in the first month after surgery by overriding muscle ...

3. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1713420

Neuromuscular Electrical Stimulation Use after Total Knee ... The TUG improvements for patients treated with NMES showed significant improvements at 6 (p = 0.018) and 12 weeks (p = 0.003) postoperatively. Use of a home- ...

4. news.cuanschutz.edu news.cuanschutz.edu/accords/doubling-the-speed-of-recovery-in-total-knee-replacement-surgery

Doubling the Speed of Recovery in Total Knee ... The study demonstrated a near double speed of recovery, showing improved functional outcomes, such as standing up from a chair, walking a set distance and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32610358/

Neuromuscular Electrical Stimulation Use after Total Knee ... Baseline measurements and outcomes were recorded at 3, 6, and 12 weeks postoperatively, and included quadriceps strength, range of motion (ROM), ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03044028

Neuromuscular Electrical Stimulation (NMES) for Improving ... The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, ...

7. trialx.com trialx.com/clinical-trials/listings/298010/implementation-of-neuromuscular-electrical-stimulation-after-total-knee-arthroplasty/?&radius=10&place=Putzu&user_country=Taiwan

Implementation of Neuromuscular Electrical Stimulation ... Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long- ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540318301086

Systematic Review of Three Electrical Stimulation ... Qualitative analysis suggested that NMES was associated with higher quadriceps strength and functional recovery after TKA. Recovery benefits were maximal when ...