Arthritis, Osteoarthritis, Knee, Pain
Conditions
Keywords
Total Knee Arthroplasty (TKA), Transcutaneous Electrical Nerve Stimulation (TENS), Pain, Function, Knee Osteoarthritis
Brief summary
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)
Detailed description
A prospective, randomized postmarket trial to assess the efficacy of the Select TENS™ Pain Management System, a transcutaneous electrical nerve stimulation (TENS) device, for reducing pain and narcotics requirement in patients managed with a total knee arthroplasty (TKA). This will be a placebo-controlled study involving 116 patients undergoing primary unilateral TKA procedures; 58 patients will be randomly selected to be treated postoperatively with an active TENS unit and the other 58 patients will be randomly selected to be treated with the placebo TENS unit (control group). Patients will be enrolled at two sites within the Cleveland Clinic Health System (Main Campus and Lutheran Hospital). Both treatment and control groups will receive a femoral nerve catheter, standard during a primary TKA. It is hypothesized that TENS (in combination with a femoral nerve catheter) can reduce narcotic usage, reduce pain, and allow for a quicker return to function following TKA.
Interventions
DEVICEEMPI Select TENS
The unit is capable of 0-60 milliamps of output current.
DEVICEPlacebo EMPI Select TENS
The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation.
Sponsors
DJO Incorporated
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing unilateral primary total knee arthroplasty * Patients who are between the ages of 18-85 years * Patient has signed informed consent
Exclusion criteria
* Patients who live \>100 miles from the Cleveland Clinic main campus (9500 Euclid Ave., Cleveland, OH 44195) * Patients who will not receive a femoral nerve catheter for surgery * Patients who are not planned to be discharged directly home following surgery * Patients who have used a TENS device in the past * Preoperative daily use of narcotics (i.e., high tolerance) * Already enrolled in another research study, including the present study for contralateral knee * Patients with a history of epilepsy * Patients with a cardiac pacemaker * Patients who are a risk for poor compliance or have a poor understanding of the use of the TENS device * Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Usage | Through 6 weeks after surgery | Morphine Equivalent dose, mg/kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Score (VAS) | 6 weeks (+/- 3 days) postoperative | Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain. |
| Functional Assessments | 6 weeks (+/- 3 days) postoperative | Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. |
| General Health Outcome - SF-12 Physical Component Summary | 6 weeks (+/- 3 days) postoperative | Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active TENS Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.
EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received. | 35 |
| Placebo TENS Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.
Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes | 31 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Protocol Violation | 2 | 4 |
| Overall Study | Withdrawal by Subject | 19 | 19 |
Baseline characteristics
| Characteristic | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 3.7 | 60.3 years STANDARD_DEVIATION 7.7 | 62.8 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 35 | 9 / 31 |
| serious Total, serious adverse events | 1 / 35 | 2 / 31 |
Outcome results
Primary
Narcotic Usage
Morphine Equivalent dose, mg/kg
Time frame: Through 6 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Narcotic Usage | 997.7 morphine equivalents | Standard Deviation 1124.9 |
| Placebo TENS | Narcotic Usage | 1025.8 morphine equivalents | Standard Deviation 1053.6 |
Secondary
Functional Assessments
Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.
Time frame: 6 weeks (+/- 3 days) postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Functional Assessments | 9.31 seconds | Standard Deviation 2.67 |
| Placebo TENS | Functional Assessments | 10.39 seconds | Standard Deviation 4.29 |
Secondary
General Health Outcome - SF-12 Physical Component Summary
Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported.
Time frame: 6 weeks (+/- 3 days) postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | General Health Outcome - SF-12 Physical Component Summary | 33.57 z-scale | Standard Deviation 7.02 |
| Placebo TENS | General Health Outcome - SF-12 Physical Component Summary | 31.78 z-scale | Standard Deviation 7.07 |
Secondary
Visual Analog Pain Score (VAS)
Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
Time frame: 6 weeks (+/- 3 days) postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Visual Analog Pain Score (VAS) | 1.57 units on a scale | Standard Deviation 1.35 |
| Placebo TENS | Visual Analog Pain Score (VAS) | 1.54 units on a scale | Standard Deviation 1.52 |