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N/A N=66 Randomized Treatment

Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)

Arthropathy of Knee Joint

Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs) — 3.35; 15.95; -5.48 lbs

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CyMedica Orthopedics QB1 e-vive™ system (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Cleveland Clinic
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)
3.35; 15.95; -5.48
SECONDARY
Knee Active Range of Motion (Extension, Flexion) in Degrees
0.50; 6.67; -1.50
SECONDARY
Visual Analogue Scale (VAS) Pain Level (0-10 Scale)
2.00; 1.80; 1.18
SECONDARY
Hospital Length of Stay (Days)
1.83; 1.75; 1.68
SECONDARY
Number of Patients Discharged to Extended Care Facility
0; 0; 1
SECONDARY
Number of Patients Readmitted to Hospital
0; 0; 1
SECONDARY
Number of Outpatient Therapy Visits (Patient Questionnaire)
12.86; 16.25; 11.67
SECONDARY
KOOS - PS
33.43; 20.39; 26.62
SECONDARY
KOOS Pain
72.22; 78.89; 80.38

Summary

The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee range of motion are often worse than preoperative levels for as long as 6 months after surgery and in some cases may persist for many years after that. Such quadriceps strength impairments after TKA have been largely attributed to voluntary activation deficits and can lead to a decrease in functional performance such as decreased gait speed, decreased balance which can lead to falls, and decreased stair climbing & chair rise abilities. Since therapy alone does not adequately restore or improve upon the preoperative functional capabilities in a consistent and timely manner, it has been suggested that NMES used adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag, increase walking speed, and improve QFM strength, knee range of motion, and function. However, NMES initiated one month after TKA did not lead to improved QFM strength or function beyond the standard benefits gained from exercise alone, thus suggesting that the timing of NMES application after TKA is important. It has previously been shown that preoperative QFM strength is predictive of postoperative function [6] but the benefit of prehabilitation remains in question. To date, there has only been one pilot study assessing the benefits of NMES when initiated preoperatively. This study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to assess the benefits of NMES both preoperatively and postoperatively in order to determine how it will be most beneficial to TKA patients.

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing unilateral primary total knee arthroplasty
  • Patients who are between the ages of 18 - 85 years
  • Patient has signed informed consent
  • Patient has access to a smartphone or tablet (Android or iOS)

Exclusion Criteria

  • BMI ≥ 40
  • Inflammatory arthritis
  • Patients who are expected to be in extended care facilities after surgery
  • Patients who have used an at-home NMES device in the past
  • Preoperative daily use of narcotics (i.e., high tolerance)
  • Already enrolled in another research study, including the present study for contralateral knee
  • Other lower-extremity orthopaedic conditions which could interfere with limb function, especially those with significant pain requiring daily analgesic intake
  • Patients with concurrent abdominal, inguinal or femoral hernias
  • Cutaneous lesions in areas of electrode pad placement
  • Patients with a history of epilepsy
  • Patients with a cardiac pacemaker/defibrillator
  • Allergy to adhesives
  • Inability to meet follow-up visits required for the study
  • Patients who are a risk for poor compliance or have a poor understanding of the use of the NMES device
  • Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03044028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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