Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Neuromuscular Electrical Stimulation (NMES); Other: Standard Rehabilitation Protocol

Detailed Description

Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. To alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty (TKA) are performed each year in the United States, and future projections indicate that by the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. A month after TKA, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery.

The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + NMES.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCD Physical Therapy Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 50-85 years of age
• Scheduled for a primary unilateral TKA
• Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion Criteria:

• History of uncontrolled hypertension or uncontrolled diabetes
• Body mass index greater than 35 kg/m^2
• Neurological, vascular or cardiac problems that significantly limit function
• Moderate or severe osteoarthritis or other orthopedic conditions in the non-operated lower extremity that limit function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neuromuscular Electrical Stimulation (NMES)	Device: Neuromuscular Electrical Stimulation (NMES); NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
ACTIVE_COMPARATOR: Standard Rehabilitation Protocol	Other: Standard Rehabilitation Protocol; Standard physical therapy for 8 weeks after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively	A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.	Baseline through 3.5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively	A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.	Baseline through 1 year
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively	The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.	3.5 weeks post-operatively
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively	The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.	3.5 weeks post-operatively
Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively	The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.	3.5 weeks post-operatively
Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively	The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.	1 year post-operatively
Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively	The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.	1 year post-operatively
Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively	The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.	1 year post-operatively

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA); American College of Rheumatology Research and Education Foundation
• Investigators: Principal Investigator: Jennifer Stevens, MPT, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• Mintken PE, Carpenter KJ, Eckhoff D, Kohrt WM, Stevens JE. Early neuromuscular electrical stimulation to optimize quadriceps muscle function following total knee arthroplasty: a case report. J Orthop Sports Phys Ther. 2007 Jul;37(7):364-71. doi: 10.2519/jospt.2007.2541.
• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
• 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.
• Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Schwartz RS, Schenkman M, Kohrt WM. Relationship between intensity of quadriceps muscle neuromuscular electrical stimulation and strength recovery after total knee arthroplasty. Phys Ther. 2012 Sep;92(9):1187-96. doi: 10.2522/ptj.20110479. Epub 2012 May 31.
• 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.

Helpful Links

• University of Colorado at Denver Muscle Performance Laboratory

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: November 30, 2008
• First Submitted That Met QC Criteria: November 30, 2008
• First Posted (ESTIMATE): December 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: electrical stimulation; muscle; total knee arthroplasty; arthroscopy; quadriceps
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 06-0074; K23AG029978-01A2 (NIH)