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
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: Neuromuscular Electrical Stimulation (NMES)
Behavioral: Standard Rehabilitation Protocol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Changes in quadriceps muscle force [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 Behavioral: Standard Rehabilitation Protocol
Standard physical therapy for 8 weeks after surgery

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800254

Locations
United States, Colorado
UCD Physical Therapy Program
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
American College of Rheumatology Research and Education Foundation
Investigators
Principal Investigator: Jennifer Stevens, MPT, PhD University of Colorado, Denver
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00800254     History of Changes
Other Study ID Numbers: 06-0074, K23AG029978-01A2
Study First Received: November 30, 2008
Last Updated: November 20, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
electrical stimulation
total knee arthroplasty
quadriceps
muscle
arthroscopy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014