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| Sponsor: | Greg Olender |
|---|---|
| Collaborators: |
National Institute on Aging (NIA) University of Colorado, Denver American College of Rheumatology Research and Education Foundation |
| Information provided by (Responsible Party): | Greg Olender, University of Colorado at Denver and Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00800254 |
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 II |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| UCD Physical Therapy Program | |
| Aurora, Colorado, United States, 80045 | |
| Principal Investigator: | Jennifer Stevens, MPT, PhD | University of Colorado, Denver |
More Information
| Responsible Party: | Greg Olender, Jennifer Stevens-Lapsley, University of Colorado at Denver and Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00800254 History of Changes |
| Other Study ID Numbers: | AG0112, K23AG029978-01A2 |
| Study First Received: | November 30, 2008 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Federal Government |
|
electrical stimulation total knee arthroplasty quadriceps muscle arthroscopy |
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |