Trial Outcomes & Findings for Effect of TENS for Pain and Function After Total Knee Replacement (NCT NCT01364870)
NCT ID: NCT01364870
Last Updated: 2017-11-30
Results Overview
While subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
317 participants
Primary outcome timeframe
1 day post-op
Results posted on
2017-11-30
Participant Flow
Participant milestones
| Measure |
Intense TENS
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
Subjects randomized to "Standard Care" will be given no TENS unit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
123
|
72
|
|
Overall Study
COMPLETED
|
100
|
93
|
58
|
|
Overall Study
NOT COMPLETED
|
22
|
30
|
14
|
Reasons for withdrawal
| Measure |
Intense TENS
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
Subjects randomized to "Standard Care" will be given no TENS unit.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
24
|
10
|
|
Overall Study
Adverse Event
|
8
|
6
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Effect of TENS for Pain and Function After Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Intense TENS
n=122 Participants
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
n=123 Participants
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
n=72 Participants
Subjects randomized to "Standard Care" will be given no TENS unit.
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.7 Years
n=5 Participants
|
61.9 Years
n=7 Participants
|
62.2 Years
n=5 Participants
|
62.3 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
310 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Pain with knee range of motion: Extension
|
6.69 scores on a scale
n=5 Participants
|
7.03 scores on a scale
n=7 Participants
|
8.03 scores on a scale
n=5 Participants
|
7.13 scores on a scale
n=4 Participants
|
|
Pain with walking
|
6.1 scores on a scale
n=5 Participants
|
6.29 scores on a scale
n=7 Participants
|
7.65 scores on a scale
n=5 Participants
|
6.52 scores on a scale
n=4 Participants
|
|
Pain at rest
|
2.92 scores on a scale
n=5 Participants
|
3.35 scores on a scale
n=7 Participants
|
3.76 scores on a scale
n=5 Participants
|
3.28 scores on a scale
n=4 Participants
|
|
Pressure Pain Threshold
|
264.08 kilopascal (kPa)
n=5 Participants
|
251.02 kilopascal (kPa)
n=7 Participants
|
247 kilopascal (kPa)
n=5 Participants
|
255.16 kilopascal (kPa)
n=4 Participants
|
|
Heat Pain Threshold
|
43.3 Degrees Celsius
n=5 Participants
|
43.3 Degrees Celsius
n=7 Participants
|
43.6 Degrees Celsius
n=5 Participants
|
43.4 Degrees Celsius
n=4 Participants
|
|
Heat Pain Tolerance
|
47.4 Degrees Celsius
n=5 Participants
|
46.8 Degrees Celsius
n=7 Participants
|
47.1 Degrees Celsius
n=5 Participants
|
47.1 Degrees Celsius
n=4 Participants
|
|
Knee Range of Motion: Extension
|
-5 Degrees
n=5 Participants
|
-4.8 Degrees
n=7 Participants
|
-6.5 Degrees
n=5 Participants
|
-5.3 Degrees
n=4 Participants
|
|
Gait Speed Test
|
61.9 feet in 15 seconds
n=5 Participants
|
62.7 feet in 15 seconds
n=7 Participants
|
60.5 feet in 15 seconds
n=5 Participants
|
61.9 feet in 15 seconds
n=4 Participants
|
|
Range of motion: Flextion
|
112.5 Degrees
n=5 Participants
|
115.4 Degrees
n=7 Participants
|
109.8 Degrees
n=5 Participants
|
113 Degrees
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 day post-opWhile subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").
Outcome measures
| Measure |
Intense TENS
n=111 Participants
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
n=121 Participants
Placebo TENS: Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
n=68 Participants
Subjects randomized to "Standard Care" will be given no TENS unit.
|
|---|---|---|---|
|
Self-Reported Pain With Movement
|
9.5 scores on a scale
Interval 0.0 to 20.0
|
10 scores on a scale
Interval 0.0 to 20.0
|
14 scores on a scale
Interval 0.0 to 20.0
|
PRIMARY outcome
Timeframe: 2 days post-opSubjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain was assessed with a Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").
Outcome measures
| Measure |
Intense TENS
n=105 Participants
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
n=115 Participants
Placebo TENS: Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
n=67 Participants
Subjects randomized to "Standard Care" will be given no TENS unit.
|
|---|---|---|---|
|
Self-reported Pain With Walking (From Iowa Gait Test)
|
8 scores on a scale
Interval 0.0 to 20.0
|
10 scores on a scale
Interval 0.0 to 20.0
|
10 scores on a scale
Interval 0.0 to 20.0
|
Adverse Events
Intense TENS
Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo TENS
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Standard Care
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intense TENS
n=122 participants at risk
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
n=123 participants at risk
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
n=72 participants at risk
Subjects randomized to "Standard Care" will be given no TENS unit.
|
|---|---|---|---|
|
Vascular disorders
Blood clot in non-surgical leg
|
0.00%
0/122
|
0.81%
1/123 • Number of events 1
|
0.00%
0/72
|
|
Vascular disorders
Blood clot in surgical leg
|
0.00%
0/122
|
0.00%
0/123
|
1.4%
1/72 • Number of events 1
|
|
Infections and infestations
Infection in surgical knee
|
3.3%
4/122 • Number of events 4
|
1.6%
2/123 • Number of events 2
|
4.2%
3/72 • Number of events 3
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/122
|
0.00%
0/123
|
1.4%
1/72 • Number of events 1
|
|
General disorders
Readmission to hospital for medication adjustment
|
0.82%
1/122 • Number of events 1
|
0.00%
0/123
|
1.4%
1/72 • Number of events 1
|
|
Surgical and medical procedures
Surgery to remove broken drain tube
|
0.82%
1/122 • Number of events 1
|
0.00%
0/123
|
0.00%
0/72
|
|
Injury, poisoning and procedural complications
Injury (torn hamstring) during physical therapy
|
0.82%
1/122 • Number of events 1
|
0.00%
0/123
|
0.00%
0/72
|
Other adverse events
| Measure |
Intense TENS
n=122 participants at risk
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
Intense TENS (EMPI Select TENS): High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
|
Placebo TENS
n=123 participants at risk
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
|
Standard Care
n=72 participants at risk
Subjects randomized to "Standard Care" will be given no TENS unit.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall at home
|
3.3%
4/122 • Number of events 4
|
5.7%
7/123 • Number of events 7
|
2.8%
2/72 • Number of events 2
|
Additional Information
Barbara Rakel, PhD, RN, FAAN
University of Iowa College of Nursing
Phone: 319-335-7036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place