Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044028
Recruitment Status : Completed
First Posted : February 6, 2017
Results First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Higuera-Rueda, The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Arthropathy of Knee Joint Device: CyMedica Orthopedics QB1 e-vive™ system Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
Study Start Date : January 2017
Actual Primary Completion Date : June 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: NMES preoperative and postoperative
Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study
Device: CyMedica Orthopedics QB1 e-vive™ system
a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
Other Name: NMES Neuromuscular electrical stimulation

Experimental: NMES postoperative only
Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study
Device: CyMedica Orthopedics QB1 e-vive™ system
a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
Other Name: NMES Neuromuscular electrical stimulation

No Intervention: No intervention
Subject will not be given device and will undergo the standard rehab protocol alone



Primary Outcome Measures :
  1. Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs) [ Time Frame: 6 weeks ]
    measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative


Secondary Outcome Measures :
  1. Knee Active Range of Motion (Extension, Flexion) in Degrees [ Time Frame: 12 weeks ]
    Measure rage of motion differences between the treatment groups

  2. Visual Analogue Scale (VAS) Pain Level (0-10 Scale) [ Time Frame: 12 weeks ]
    Differences in VAS scores between the treatment groups from baseline to 12 weeks postop. Higher score represents worse pain.

  3. Hospital Length of Stay (Days) [ Time Frame: 12 weeks ]
    differences in length of stay between the treatment groups

  4. Number of Patients Discharged to Extended Care Facility [ Time Frame: 12 weeks ]
    Patent discharge other than "home" to extended care facility

  5. Number of Patients Readmitted to Hospital [ Time Frame: 12 weeks ]
    Number of all-cause readmissions to the hospital

  6. Number of Outpatient Therapy Visits (Patient Questionnaire) [ Time Frame: 12 weeks ]
    Difference in number of outpatient therapy visits among the treatment groups

  7. KOOS - PS [ Time Frame: 12 weeks ]
    Functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function Shortform (PS) questionnaire. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.

  8. KOOS Pain [ Time Frame: 12 weeks ]
    Measure pain at 12 weeks postoperative using Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscore. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. BMI ≥ 40
  2. Inflammatory arthritis
  3. Patients who are expected to be in extended care facilities after surgery
  4. Patients who have used an at-home NMES device in the past
  5. Preoperative daily use of narcotics (i.e., high tolerance)
  6. Already enrolled in another research study, including the present study for contralateral knee
  7. Other lower-extremity orthopaedic conditions which could interfere with limb function, especially those with significant pain requiring daily analgesic intake
  8. Patients with concurrent abdominal, inguinal or femoral hernias
  9. Cutaneous lesions in areas of electrode pad placement
  10. Patients with a history of epilepsy
  11. Patients with a cardiac pacemaker/defibrillator
  12. Allergy to adhesives
  13. Inability to meet follow-up visits required for the study
  14. Patients who are a risk for poor compliance or have a poor understanding of the use of the NMES device
  15. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044028


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Study Chair: Michael Mont The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Carlos Higuera-Rueda, The Cleveland Clinic:

Publications:
Klika AK, Gehrig M, Boukis L, Milidonis MK, Smith DA, Murray TG, Barsoum WK. A Rapid Recovery Program After Total Knee Arthroplasty. Semin Arthro. 2009; 20:40-44.

Layout table for additonal information
Responsible Party: Carlos Higuera-Rueda, Staff Surgeon, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03044028    
Other Study ID Numbers: #16-1293
First Posted: February 6, 2017    Key Record Dates
Results First Posted: March 5, 2020
Last Update Posted: March 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases