Osteoarthritis
Conditions
Keywords
electrical stimulation, total knee arthroplasty, quadriceps, muscle, arthroscopy
Brief summary
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.
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.
Interventions
DEVICENeuromuscular Electrical Stimulation (NMES)
NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
Standard physical therapy for 8 weeks after surgery
Sponsors
National Institute on Aging (NIA)
American College of Rheumatology Research and Education Foundation
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively | Baseline through 3.5 weeks | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively | 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. |
| Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively | 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. |
| Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively | 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. |
| Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively | Baseline through 1 year | A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion. |
| Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively | 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. |
| Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively | 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. |
| Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neuromuscular Electrical Stimulation (NMES) Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy | 35 |
| Standard Rehabilitation Protocol (Control) Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery | 31 |
| Total | 66 |
Baseline characteristics
| Characteristic | Neuromuscular Electrical Stimulation (NMES) | Standard Rehabilitation Protocol (Control) | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 9.1 | 64.8 years STANDARD_DEVIATION 7.7 | 65.5 years STANDARD_DEVIATION 8.4 |
| Body Mass Index (BMI) | 27.1 kg/m^2 STANDARD_DEVIATION 4.9 | 31.2 kg/m^2 STANDARD_DEVIATION 4.2 | 29.2 kg/m^2 STANDARD_DEVIATION 4.6 |
| Sex: Female, Male Female | 20 Participants | 16 Participants | 36 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 31 |
| serious Total, serious adverse events | 3 / 35 | 3 / 31 |
Outcome results
Primary
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.
Time frame: Baseline through 3.5 weeks
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively | -0.40 change in N-m/kg | Standard Error 0.05 |
| Standard Rehabilitation Protocol (Control) | Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively | -0.67 change in N-m/kg | Standard Error 0.06 |
p-value: <0.001ANCOVA
Secondary
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.
Time frame: Baseline through 1 year
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively | 0.33 change in N-m/kg | Standard Deviation 0.52 |
| Standard Rehabilitation Protocol (Control) | Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively | 0.18 change in N-m/kg | Standard Deviation 0.43 |
Secondary
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.
Time frame: 1 year post-operatively
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively | 524.6 meters | Standard Deviation 81.6 |
| Standard Rehabilitation Protocol (Control) | Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively | 477.8 meters | Standard Deviation 94 |
Secondary
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.
Time frame: 3.5 weeks post-operatively
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively | 390.1 meters | Standard Deviation 92.4 |
| Standard Rehabilitation Protocol (Control) | Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively | 295.3 meters | Standard Deviation 103.4 |
p-value: <0.003ANCOVA
Secondary
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.
Time frame: 1 year post-operatively
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively | 11.5 seconds | Standard Deviation 4.3 |
| Standard Rehabilitation Protocol (Control) | Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively | 14.8 seconds | Standard Deviation 9.3 |
Secondary
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.
Time frame: 3.5 weeks post-operatively
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively | 25.2 seconds | Standard Deviation 10.4 |
| Standard Rehabilitation Protocol (Control) | Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively | 39.3 seconds | Standard Deviation 13.9 |
Secondary
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.
Time frame: 1 year post-operatively
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively | 6.7 seconds | Standard Deviation 1.7 |
| Standard Rehabilitation Protocol (Control) | Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively | 8.3 seconds | Standard Deviation 2.8 |
Secondary
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.
Time frame: 3.5 weeks post-operatively
Population: The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Electrical Stimulation (NMES) | Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively | 10.4 seconds | Standard Deviation 3.8 |
| Standard Rehabilitation Protocol (Control) | Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively | 13.9 seconds | Standard Deviation 4.5 |