Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2029-04-30

Brief Summary

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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.

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Detailed Description

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Total Knee Arthroplasty (TKA) reduces pain and disability caused by knee osteoarthritis, but the surgery results in substantial trauma to the knee. This acute trauma exacerbates underlying weakness-especially in the quadriceps. This leads to muscle atrophy and likely contributes to the long-term weakness and disability patients with TKA experience relative to their healthy peers. Attenuating quadriceps strength loss should be a primary target for improving rehabilitation outcomes after TKA.

Neuromuscular electrical stimulation (NMES) is recommended in TKA clinical practice guidelines to attenuate quadriceps strength loss. In controlled settings, NMES has established efficacy and attenuates quadriceps strength loss by 40% in the first month after surgery by overriding muscle activation deficits and reducing muscle atrophy. However, the effectiveness of NMES after TKA has not been adequately studied in real-world clinical settings, and preliminary data suggests that less than 4% of rehabilitation clinicians are using NMES as recommended by current TKA practice guidelines.

To address this gap, the investigators will conduct a cluster randomized trial in two healthcare systems (UCHealth and Intermountain Health) and their associated outpatient physical therapy clinics (n=30) to evaluate the effectiveness and implementation of NMES to address musculoskeletal deficits after TKA.

The investigators will compare outcomes between patients who receive contemporary rehabilitation supported by a comprehensive NMES implementation strategy (NMES) to patients who receive contemporary musculoskeletal rehabilitation alone (Usual Care; Aim 1). The investigators will gather information on NMES implementation to promote its uptake and translation to clinical practice (Aim 2).

Conditions

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Total Knee Arthroplasty Functional Recovery Aging Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Investigators will not be blinded to the arms due to facility/clinician training required for this study design. Study sites (i.e., outpatient physical therapy clinics) will be the unit of randomization. Study sites will be made broadly aware of the study initiative during the site recruitment process; however, the site will not be provided with detailed information about the intervention unless randomized to the Intervention arm. As such, clinicians, or rehabilitation care providers, at usual care sites will remain blinded to the intervention for the duration of the study. Clinicians will collect patient-level functional outcomes as part of their standard of care and all patients who are subjects of the intervention will not be aware of the group allocation in the study.

Study Groups

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NMES

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 Type EXPERIMENTAL

NMES

Intervention Type PROCEDURE

The NMES intervention protocol in this study ensures patients receive NMES intervention that is adequately dosed (dose = treatment minutes x intensity), delivered using evidence-based parameters, and feasible. The investigators will deliver NMES using a portable two-channel stimulator that the investigators have found to produce stronger muscle contractions than other portable NMES units and has been used in previous clinical studies. It also has a built-in compliance meter to monitor patient treatment minutes (adherence) to NMES application. NMES sites will perform routine collection of outcomes as part of standard practice.

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual Care clinics will continue with routine collection and documentation of physical performance outcomes as standard practice. A combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Usual Care clinics including the facility, rehabilitation clinicians, and patients will not have access to NMES materials developed for this study.

Interventions

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NMES

The NMES intervention protocol in this study ensures patients receive NMES intervention that is adequately dosed (dose = treatment minutes x intensity), delivered using evidence-based parameters, and feasible. The investigators will deliver NMES using a portable two-channel stimulator that the investigators have found to produce stronger muscle contractions than other portable NMES units and has been used in previous clinical studies. It also has a built-in compliance meter to monitor patient treatment minutes (adherence) to NMES application. NMES sites will perform routine collection of outcomes as part of standard practice.

Intervention Type PROCEDURE

Usual Care

Usual Care clinics will continue with routine collection and documentation of physical performance outcomes as standard practice. A combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Usual Care clinics including the facility, rehabilitation clinicians, and patients will not have access to NMES materials developed for this study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• UCHealth or Intermountain Health outpatient physical therapy clinic

* Underwent primary unilateral TKA
* Attended outpatient rehabilitation at a participating clinic within 5 days after TKA
* Attended at least 3 total outpatient physical therapy visits in total

Exclusion Criteria

* NMES Contraindications \[Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity\]
* Previous lower extremity arthroplasty less than 12 weeks prior to scheduled TKA surgical date

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No