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

NCT03044028 | Completed Results DMC

• 1 other identifier: #16-1293
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (1)

• Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)

  measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative

  6 weeks

Secondary Outcomes (8)

• Knee Active Range of Motion (Extension, Flexion) in Degrees

  12 weeks

• Visual Analogue Scale (VAS) Pain Level (0-10 Scale)

  12 weeks

• Hospital Length of Stay (Days)

  12 weeks

• Number of Patients Discharged to Extended Care Facility

  12 weeks

• Number of Patients Readmitted to Hospital

  12 weeks

Study Arms (3)

NMES preoperative and postoperative

EXPERIMENTAL

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

NMES postoperative only

EXPERIMENTAL

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

No intervention

NO INTERVENTION

Subject will not be given device and will undergo the standard rehab protocol alone

Interventions

CyMedica Orthopedics QB1 e-vive™ system DEVICE

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).

Also known as: NMES Neuromuscular electrical stimulation

NMES postoperative only; NMES preoperative and postoperative

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (16)

• Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.

  PMID: 22095207 BACKGROUND

• Levine M, McElroy K, Stakich V, Cicco J. Comparing conventional physical therapy rehabilitation with neuromuscular electrical stimulation after TKA. Orthopedics. 2013 Mar;36(3):e319-24. doi: 10.3928/01477447-20130222-20.

  PMID: 23464951 BACKGROUND

• Gotlin RS, Hershkowitz S, Juris PM, Gonzalez EG, Scott WN, Insall JN. Electrical stimulation effect on extensor lag and length of hospital stay after total knee arthroplasty. Arch Phys Med Rehabil. 1994 Sep;75(9):957-9.

  PMID: 8085929 BACKGROUND

• Avramidis K, Karachalios T, Popotonasios K, Sacorafas D, Papathanasiades AA, Malizos KN. Does electric stimulation of the vastus medialis muscle influence rehabilitation after total knee replacement? Orthopedics. 2011 Mar 11;34(3):175. doi: 10.3928/01477447-20110124-06.

  PMID: 21410130 BACKGROUND

• Petterson SC, Mizner RL, Stevens JE, Raisis L, Bodenstab A, Newcomb W, Snyder-Mackler L. Improved function from progressive strengthening interventions after total knee arthroplasty: a randomized clinical trial with an imbedded prospective cohort. Arthritis Rheum. 2009 Feb 15;61(2):174-83. doi: 10.1002/art.24167.

  PMID: 19177542 BACKGROUND

• Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.

  PMID: 16078331 BACKGROUND

• D'Lima DD, Colwell CW Jr, Morris BA, Hardwick ME, Kozin F. The effect of preoperative exercise on total knee replacement outcomes. Clin Orthop Relat Res. 1996 May;(326):174-82. doi: 10.1097/00003086-199605000-00020.

  PMID: 8620638 BACKGROUND

• Villadsen A. Neuromuscular exercise prior to joint arthroplasty in patients with osteoarthritis of the hip or knee. Dan Med J. 2016 Apr;63(4):B5235. No abstract available.

  PMID: 27034190 BACKGROUND

• Rodgers JA, Garvin KL, Walker CW, Morford D, Urban J, Bedard J. Preoperative physical therapy in primary total knee arthroplasty. J Arthroplasty. 1998 Jun;13(4):414-21. doi: 10.1016/s0883-5403(98)90007-9.

  PMID: 9645522 BACKGROUND

• Walls RJ, McHugh G, O'Gorman DJ, Moyna NM, O'Byrne JM. Effects of preoperative neuromuscular electrical stimulation on quadriceps strength and functional recovery in total knee arthroplasty. A pilot study. BMC Musculoskelet Disord. 2010 Jun 14;11:119. doi: 10.1186/1471-2474-11-119.

  PMID: 20540807 BACKGROUND

• 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.

  BACKGROUND

• Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

  PMID: 9699158 BACKGROUND

• Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004 Sep;42(9):851-9. doi: 10.1097/01.mlr.0000135827.18610.0d.

  PMID: 15319610 BACKGROUND

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

Results Point of Contact

• Title: Carlos Higuera
• Organization: Cleveland Clinic

higuerc@ccf.org

954-659-5430

Study Officials

• Michael Mont

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: February 6, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 5, 2020
• Results First Posted: March 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)