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

This study has been completed.
Sponsor:
Collaborators:
American College of Rheumatology Research and Education Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00800254
First received: November 30, 2008
Last updated: November 20, 2012
Last verified: November 2012

November 30, 2008
November 20, 2012
October 2008
December 2010   (final data collection date for primary outcome measure)
Changes in quadriceps muscle force [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
Changes in quadriceps muscle force [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00800254 on ClinicalTrials.gov Archive Site
  • Changes in quadriceps activation and size,quadriceps muscle activity (EMG) during functional activities [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
  • Functional performance measures (self-reports, 6 minute walk distance, get up and go time, and functional stair climbing time) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
  • Changes in quadriceps activation and size, presynaptic inhibition (H- reflexes), quadriceps muscle activity (EMG) during functional activities [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
  • Functional performance measures (self-reports, 6 minute walk distance, get up and go time, and functional stair climbing time) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
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 replacement (TKR) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Procedure: Neuromuscular Electrical Stimulation (NMES)
    20 minutes twice a day for 6 weeks
  • Behavioral: Standard Rehabilitation Protocol
    Standard physical therapy for 8 weeks after surgery
  • Experimental: 1
    Interventions:
    • Procedure: Neuromuscular Electrical Stimulation (NMES)
    • Behavioral: Standard Rehabilitation Protocol
  • Active Comparator: 2
    Intervention: Behavioral: Standard Rehabilitation Protocol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
November 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 50 years of age or older
  • Scheduled for a unilateral or bilateral primary TKR
  • Body mass index less than 35
  • Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Exclusion Criteria:

  • History of uncontrolled diabetes; HbA1c levels greater than 8%
  • 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
  • Alcoholism or drug abuse
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00800254
06-0074, K23AG029978-01A2
No
University of Colorado, Denver
University of Colorado, Denver
  • National Institute on Aging (NIA)
  • American College of Rheumatology Research and Education Foundation
Principal Investigator: Jennifer Stevens, MPT, PhD University of Colorado, Denver
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP