Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DJO Incorporated | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of Electrical Nerve Stimulation (TENS) Therapy for Pain Relieft Following Total Knee Arrhtoplasty (TKA)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS | Experimental | Active TENS (EMPI Select 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. |
|
| Placebo TENS | Placebo Comparator | Placebo TENS (Placebo EMPI Select 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMPI Select TENS | Device | The unit is capable of 0-60 milliamps of output current. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Usage | Morphine Equivalent dose, mg/kg | Through 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks (+/- 3 days) postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wael K Barsoum, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6332127 | Background | Cornell PE, Lopez AL, Malofsky H. Pain reduction with transcutaneous electrical nerve stimulation after foot surgery. J Foot Surg. 1984 Jul-Aug;23(4):326-33. | |
| 3490659 | Background | Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. doi: 10.3928/0147-7447-19861001-06. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Narcotic Usage | Morphine Equivalent dose, mg/kg | Posted | Mean | Standard Deviation | morphine equivalents | Through 6 weeks after surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blisters | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Program Manager | Cleveland Clinic - Section of Adult Reconstrution | 216-444-4954 | klikaa@ccf.org |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D001168 | Arthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo EMPI Select TENS |
| Device |
The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation. |
|
| 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. |
| 6 weeks (+/- 3 days) postoperative |
| 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. | 6 weeks (+/- 3 days) postoperative |
| 12600800 | Background | Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8. |
| 14716650 | Background | Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3. |
| Protocol Violation |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks (+/- 3 days) postoperative |
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | 6 weeks (+/- 3 days) postoperative |
|
|
|
| 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. | Posted | Mean | Standard Deviation | z-scale | 6 weeks (+/- 3 days) postoperative |
|
|
|
| 1 |
| 35 |
| 10 |
| 35 |
| EG001 | 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 | 2 | 31 | 9 | 31 |
| Delirium | Nervous system disorders | Non-systematic Assessment |
|
| Swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Intraoperative MCL tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Postoperative ligament tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |