Traumatic Amputation
Conditions
Keywords
Case Management, Amputation, Muscle strength, phantom limb pain
Brief summary
The purpose of this randomized control study is to determine if administering neuromuscular electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more effective than the current standard of care in preserving thigh muscle strength. In addition, this study will examine the NMES treatment effects on the participant's gait, quality of life, functional performance of standing, walking, and stair climbing, and symptoms associated with residual and phantom limb pain. The primary aim is to compare NMES plus standard rehabilitation (treatment group) to the standard rehabilitation (control group) by measuring lower extremity muscle strength. The secondary aims are to compare NMES treatment group to the control group by measuring Quality of Life (QOL) and the symptoms associated with residual & phantom limb pain. In addition to the specific aims, this study will also examine the two groups for functional performance and gait patterns after prosthetic fitting.
Detailed description
Traumatic amputation is one of the major injuries seen as a result of Operation Iraqi and Enduring Freedom with the majority being single trans-tibial amputations (TTA). TTA experience significant reductions in thigh muscle strength of the amputated limb during the first year after amputation. The residual limb is less active in daily functions of standing and walking, resulting in progressive atrophy of the quadriceps muscles in terms of a decrease in thigh diameter which is estimated at 25% of pre-amputation diameter. An intervention that may be useful in TTA rehabilitation is neuromuscular electrical stimulation (NMES). The overall objectives of this study is to test two different approaches to prosthetic rehabilitation as potential treatments for improving muscle strength, pain and functional performance of daily activities in military personnel with TTA. Our central hypothesis is that a Nurse Managed NMES rehabilitation program will have greater improvements in muscle strength and pain as compared to the standard rehabilitation protocol alone. The rationale for this study is that NMES could have an additive effect to the Walter Reed Army Medical Center (WRAMC) standard of care program with greater improvements in muscle strength thus enhancing the performance of daily activities, Quality of Life (QOL), and decreasing disability. Such outcomes will ultimately result in decreased economic costs, accelerated rehabilitation, and potentially increase the possibility of these warriors returning to duty. The specific aims are to test Nurse Managed NMES relative to standard rehabilitation by comparing: (1) Lower extremity muscle strength; (2) QOL; and (3) Symptoms associated with phantom pain. In addition to the above aims, specific aims for the post prosthetic phase of the intervention are to compare the two groups for (4) functional performance of daily activities. After pre-testing, participants aged 18 to 55 yrs with a traumatic TTA will be randomly assigned to either the 1) Nurse Managed NMES rehabilitation program (n=30); or 2) WRAMC Amputee Protocol (n=30). Those in the NMES group will receive 12 weeks of electrical muscle stimulation 15 min/day, 5 days a week for 12 weeks. Both groups will receive the standard 12-week Walter Reed Army Medical Center rehabilitation protocol. Generalized Estimating Equation methods will be used to build regression models for statistical analysis of the longitudinal data. The significance of this research is that Nurse Managed NMES may be very important for accelerating the rehabilitation of amputees so they can achieve functional independence and regain lost muscle strength in preparation for return to duty.
Interventions
DEVICENMES (EMPI 300PV stimulator) plus standard of care
In addition to the standard rehabilitation, the NMES treatment group will receive neuromuscular electrical stimulation to the quadriceps muscle of the residual and intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of performing 15 to 20 minute stimulation sessions with a 5-minute patient treatment log, 5 times per week for 12 weeks. During each training session, 15 NMES contractions per leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home.
BEHAVIORALTMARP standard of care
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
Sponsors
Walter Reed National Military Medical Center
United States Naval Medical Center, San Diego
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Unilateral trans-tibial amputee; 2. Military service member at the time of injury (Active Duty, Reserves or National Guard); 3. Age ≥18 and ≤55 years; and 4. Able to provide freely given informed consent.
Exclusion criteria
1. A significant co-morbid medical condition (such as severe uncontrolled hypertension (over 160/100 mmHg) or neurological disorders such as epilepsy) where NMES strength training is contraindicated and/or participation would pose a safety threat or impair their ability to participate; 2. Unable to speak and read English; 3. Implanted cardiac pacemaker or defibrillator; 4. Vision impairment where participant is classified as legally blind (we define legally blind both clinically and functionally. Clinically, it is central visual acuity of 20/200 or less in the better eye with corrective glasses. Functionally, the participant is not able to see the digital numbers on the NMES device with corrective glasses); 5. Unwillingness to accept random assignment; 6. Currently participating in another research study with an intervention that would potentially confound the outcome variables of this study (we will also instruct participants that joining a study after being enrolled in this protocol is also not allowed); and 7. Conflicting co-morbidities including traumatic brain injury (score \< 14 on glasgow coma scale), and a contralateral lower extremity injury that causes antalgic gait, pain \> 5/10 consistently on the contralateral limb and/or a grade of \< 4+/5 in lower extremity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Mobility-Chair Rise | 6, 12 wks | Mobility was measured by the number of stands during the 30-second chair rise test. |
| Lower Extremity Mobility- Up and Go | 6, 12 wks | Mobility was measured by the time to complete an up and go test. |
| Lower Extremity Mobility- Stair Climb | 6, 12 wks | Mobility was measured by the time to complete a timed stair climb. |
| Lower Extremity Muscle Strength- Extension | 0, 3, 6, 9, 12 wks | Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb. |
| Lower Extremity Muscle Strength- Flexion | 0, 3, 6, 9, 12 wks | Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb. |
| Lower Extremity Mobility-Distance | 6, 12 wks | Mobility was measured by the distance walked in 2 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | 0, 3, 6, 9, 12 wks | Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items. |
| Pain Severity | 0, 3, 6, 9, 12 wks | Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its worst, least, average, and current level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items. |
Countries
United States
Participant flow
Pre-assignment details
There was a total of 44 participants.
Participants by arm
| Arm | Count |
|---|---|
| Standard Rehabilitation Protocol The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation. | 21 |
| NMES Plus Standard Rehabilitation Protocol NMES (EMPI 300PV stimulator) plus TMARP standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3 X 5 electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits. | 23 |
| Total | 44 |
Baseline characteristics
| Characteristic | NMES Plus Standard Rehabilitation Protocol | Standard Rehabilitation Protocol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 21 Participants | 44 Participants |
| Age, Continuous | 26.5 years STANDARD_DEVIATION 5.9 | 27.1 years STANDARD_DEVIATION 6.3 | 26.5 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment United States | 23 participants | 21 participants | 44 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 |
Outcome results
Primary
Lower Extremity Mobility-Chair Rise
Mobility was measured by the number of stands during the 30-second chair rise test.
Time frame: 6, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Lower Extremity Mobility-Chair Rise | Week 6 | 18.1 Number of stands | Standard Deviation 11.4 |
| Standard Rehabilitation Protocol | Lower Extremity Mobility-Chair Rise | Week 12 | 21.7 Number of stands | Standard Deviation 9.9 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility-Chair Rise | Week 6 | 15.7 Number of stands | Standard Deviation 8.4 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility-Chair Rise | Week 12 | 19.4 Number of stands | Standard Deviation 9.2 |
Primary
Lower Extremity Mobility-Distance
Mobility was measured by the distance walked in 2 minutes.
Time frame: 6, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Usual Pace: Week 6 | 5081 inches | Standard Deviation 2324 |
| Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Usual Pace: Week 12 | 5853 inches | Standard Deviation 2420 |
| Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Fast Pace: Week 6 | 7308 inches | Standard Deviation 2557 |
| Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Fast Pace: Week 12 | 8116 inches | Standard Deviation 2763 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Fast Pace: Week 12 | 7692 inches | Standard Deviation 2072 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Usual Pace: Week 6 | 4452 inches | Standard Deviation 1949 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Fast Pace: Week 6 | 6369 inches | Standard Deviation 2316 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility-Distance | Usual Pace: Week 12 | 5657 inches | Standard Deviation 1919 |
Primary
Lower Extremity Mobility- Stair Climb
Mobility was measured by the time to complete a timed stair climb.
Time frame: 6, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Lower Extremity Mobility- Stair Climb | Week 6 | 7.8 Seconds | Standard Deviation 3.8 |
| Standard Rehabilitation Protocol | Lower Extremity Mobility- Stair Climb | Week 12 | 4.7 Seconds | Standard Deviation 3.3 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility- Stair Climb | Week 6 | 7.5 Seconds | Standard Deviation 4.4 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility- Stair Climb | Week 12 | 5.6 Seconds | Standard Deviation 4 |
Primary
Lower Extremity Mobility- Up and Go
Mobility was measured by the time to complete an up and go test.
Time frame: 6, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Lower Extremity Mobility- Up and Go | Week 12 | 6.3 Seconds | Standard Deviation 3.5 |
| Standard Rehabilitation Protocol | Lower Extremity Mobility- Up and Go | Week 6 | 7.3 Seconds | Standard Deviation 3.9 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility- Up and Go | Week 6 | 7.7 Seconds | Standard Deviation 4.8 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Mobility- Up and Go | Week 12 | 7.1 Seconds | Standard Deviation 4.4 |
Primary
Lower Extremity Muscle Strength- Extension
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Time frame: 0, 3, 6, 9, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 0 | 24.5 Kilograms | Standard Deviation 10.7 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 3 | 27.6 Kilograms | Standard Deviation 12.5 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 6 | 33.8 Kilograms | Standard Deviation 17.3 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 9 | 35.7 Kilograms | Standard Deviation 14 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 12 | 36.1 Kilograms | Standard Deviation 15.4 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 0 | 45.7 Kilograms | Standard Deviation 23.8 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 3 | 45.2 Kilograms | Standard Deviation 24.3 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 6 | 45.0 Kilograms | Standard Deviation 19.5 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 9 | 46.0 Kilograms | Standard Deviation 16.7 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 12 | 49.0 Kilograms | Standard Deviation 20.7 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 6 | 45.2 Kilograms | Standard Deviation 13.7 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 0 | 26.4 Kilograms | Standard Deviation 13.4 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 0 | 45.4 Kilograms | Standard Deviation 17.6 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 3 | 34.1 Kilograms | Standard Deviation 12.7 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 12 | 51.8 Kilograms | Standard Deviation 16.6 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 6 | 36.9 Kilograms | Standard Deviation 12.6 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 3 | 41.4 Kilograms | Standard Deviation 16.1 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 9 | 39.1 Kilograms | Standard Deviation 16.5 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Intact Limb: Week 9 | 45.7 Kilograms | Standard Deviation 16.1 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Extension | Residual Limb: Week 12 | 42.8 Kilograms | Standard Deviation 14.8 |
p-value: <0.05Mixed Models Analysis
Primary
Lower Extremity Muscle Strength- Flexion
Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.
Time frame: 0, 3, 6, 9, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 0 | 14.8 Kilograms | Standard Deviation 8.5 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 3 | 14.8 Kilograms | Standard Deviation 7.4 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 6 | 16.8 Kilograms | Standard Deviation 7.3 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 9 | 18.4 Kilograms | Standard Deviation 7.5 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 12 | 19.5 Kilograms | Standard Deviation 8.4 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 0 | 25.4 Kilograms | Standard Deviation 7.1 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 3 | 27.1 Kilograms | Standard Deviation 10.2 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 6 | 26.9 Kilograms | Standard Deviation 10.9 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 9 | 28.8 Kilograms | Standard Deviation 9.9 |
| Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 12 | 28.8 Kilograms | Standard Deviation 10.1 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 6 | 32.2 Kilograms | Standard Deviation 10.3 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 0 | 14.2 Kilograms | Standard Deviation 6.2 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 0 | 27.8 Kilograms | Standard Deviation 10.7 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 3 | 16.7 Kilograms | Standard Deviation 7 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 12 | 29.4 Kilograms | Standard Deviation 9.9 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 6 | 18.7 Kilograms | Standard Deviation 6.9 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 3 | 28.7 Kilograms | Standard Deviation 9.4 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 9 | 19.9 Kilograms | Standard Deviation 7.6 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Intact Limb: Week 9 | 30.9 Kilograms | Standard Deviation 9.7 |
| NMES Plus Standard Rehabilitation Protocol | Lower Extremity Muscle Strength- Flexion | Residual Limb: Week 12 | 21.8 Kilograms | Standard Deviation 6.6 |
Secondary
Pain Interference
Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items.
Time frame: 0, 3, 6, 9, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Pain Interference | Week 3 | 2.5 units on a scale | Standard Deviation 2.2 |
| Standard Rehabilitation Protocol | Pain Interference | Week 9 | 2.0 units on a scale | Standard Deviation 2.5 |
| Standard Rehabilitation Protocol | Pain Interference | Week 6 | 2.3 units on a scale | Standard Deviation 2.6 |
| Standard Rehabilitation Protocol | Pain Interference | Week 12 | 2.1 units on a scale | Standard Deviation 2.5 |
| Standard Rehabilitation Protocol | Pain Interference | Week 0 | 2.9 units on a scale | Standard Deviation 2.4 |
| NMES Plus Standard Rehabilitation Protocol | Pain Interference | Week 12 | 2.7 units on a scale | Standard Deviation 2.8 |
| NMES Plus Standard Rehabilitation Protocol | Pain Interference | Week 0 | 3.1 units on a scale | Standard Deviation 2.4 |
| NMES Plus Standard Rehabilitation Protocol | Pain Interference | Week 3 | 2.2 units on a scale | Standard Deviation 2 |
| NMES Plus Standard Rehabilitation Protocol | Pain Interference | Week 6 | 2.4 units on a scale | Standard Deviation 2.3 |
| NMES Plus Standard Rehabilitation Protocol | Pain Interference | Week 9 | 2.8 units on a scale | Standard Deviation 2.7 |
Secondary
Pain Severity
Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its worst, least, average, and current level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items.
Time frame: 0, 3, 6, 9, 12 wks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Rehabilitation Protocol | Pain Severity | Week 3 | 2.6 units on a scale | Standard Deviation 1.4 |
| Standard Rehabilitation Protocol | Pain Severity | Week 9 | 2.2 units on a scale | Standard Deviation 1.6 |
| Standard Rehabilitation Protocol | Pain Severity | Week 6 | 2.2 units on a scale | Standard Deviation 1.7 |
| Standard Rehabilitation Protocol | Pain Severity | Week 12 | 1.8 units on a scale | Standard Deviation 1.6 |
| Standard Rehabilitation Protocol | Pain Severity | Week 0 | 2.9 units on a scale | Standard Deviation 1.5 |
| NMES Plus Standard Rehabilitation Protocol | Pain Severity | Week 12 | 2.4 units on a scale | Standard Deviation 1.9 |
| NMES Plus Standard Rehabilitation Protocol | Pain Severity | Week 0 | 3.3 units on a scale | Standard Deviation 1.6 |
| NMES Plus Standard Rehabilitation Protocol | Pain Severity | Week 3 | 2.4 units on a scale | Standard Deviation 1.6 |
| NMES Plus Standard Rehabilitation Protocol | Pain Severity | Week 6 | 2.2 units on a scale | Standard Deviation 1.4 |
| NMES Plus Standard Rehabilitation Protocol | Pain Severity | Week 9 | 2.6 units on a scale | Standard Deviation 1.7 |
p-value: <0.05Regression, Linear