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

Trial Summary

What is the purpose of this trial?

Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long-term function after surgery. Neuromuscular electrical stimulation (NMES) reduces quadriceps weakness and improves patient function after knee replacement, but it is drastically underused in rehabilitation practice. This randomized trial will examine the effectiveness and feasibility of a comprehensive strategy for implementing neuromuscular electrical stimulation after knee replacement in two large healthcare organizations.

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 data supports the effectiveness of the treatment NMES for total knee replacement?

Research shows that neuromuscular electrical stimulation (NMES) can help improve quadriceps muscle strength after total knee replacement, which is important for recovery and function. Studies have found that NMES can be an effective addition to traditional strengthening exercises, helping patients regain strength in their leg muscles. ^{1 2 3 4 5}

Is neuromuscular electrical stimulation (NMES) safe for humans, especially after knee replacement surgery?

Research indicates that NMES is generally safe for humans, including those with metallic implants after knee replacement surgery. Patients in studies found NMES comfortable and acceptable, with no hypersensitivity reported at implant sites. ^{1 2 3 4 6}

How is the treatment NMES different from other treatments for total knee replacement?

Neuromuscular Electrical Stimulation (NMES) is unique because it uses electrical impulses to strengthen the quadriceps muscle, which can help improve muscle strength and function before and after total knee replacement surgery. Unlike traditional physical therapy, NMES directly stimulates the muscles, potentially enhancing recovery and reducing muscle weakness more effectively. ^{1 2 3 4 5}

Research Team

Jennifer Stevens-Lapsley, PT, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of the Effect of Sensory-Level and Conventional Motor-Level Neuromuscular Electrical Stimulations on Quadriceps Strength After Total Knee Arthroplasty: A Prospective Randomized Single-Blind Trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A clinical trial of neuromuscular electrical stimulation in improving quadriceps muscle strength and activation among women with mild and moderate osteoarthritis. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Surface neuromuscular electrical stimulation for quadriceps strengthening pre and post total knee replacement. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acute effects of multipath electrical stimulation in patients with total knee arthroplasty. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Relationship between intensity of quadriceps muscle neuromuscular electrical stimulation and strength recovery after total knee arthroplasty. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The influence of orthopaedic implants on patient tolerance of neuromuscular electrical stimulation (NMES). [2020]