Trial Outcomes & Findings for Pulsed Electromagnetic Fields for Postoperative Analgesia: A Randomized, Triple-Masked, Sham-Controlled Pilot Study (NCT NCT05399355)
NCT ID: NCT05399355
Last Updated: 2024-07-31
Results Overview
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7
Results posted on
2024-07-31
Participant Flow
Participant milestones
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
|
Overall Study
COMPLETED
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 15 • n=59 Participants
|
59 years
STANDARD_DEVIATION 16 • n=60 Participants
|
58 years
STANDARD_DEVIATION 15 • n=119 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=59 Participants
|
44 Participants
n=60 Participants
|
78 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=59 Participants
|
16 Participants
n=60 Participants
|
41 Participants
n=119 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
59 participants
n=59 Participants
|
60 participants
n=60 Participants
|
119 participants
n=119 Participants
|
|
Height
|
170 cm
STANDARD_DEVIATION 10 • n=59 Participants
|
169 cm
STANDARD_DEVIATION 10 • n=60 Participants
|
169 cm
STANDARD_DEVIATION 10 • n=119 Participants
|
|
Weight
|
78 kg
STANDARD_DEVIATION 19 • n=59 Participants
|
79 kg
STANDARD_DEVIATION 17 • n=60 Participants
|
78 kg
STANDARD_DEVIATION 18 • n=119 Participants
|
|
Body Mass Index
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=59 Participants
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=60 Participants
|
27 kg/m^2
STANDARD_DEVIATION 5 • n=119 Participants
|
|
Surgery duration
|
86 minutes
STANDARD_DEVIATION 29 • n=59 Participants
|
93 minutes
STANDARD_DEVIATION 39 • n=60 Participants
|
89 minutes
STANDARD_DEVIATION 34 • n=119 Participants
|
|
Breast Surgery
|
14 Participants
n=59 Participants
|
15 Participants
n=60 Participants
|
29 Participants
n=119 Participants
|
|
Cholecystectomy
|
7 Participants
n=59 Participants
|
6 Participants
n=60 Participants
|
13 Participants
n=119 Participants
|
|
Hernia
|
8 Participants
n=59 Participants
|
9 Participants
n=60 Participants
|
17 Participants
n=119 Participants
|
|
Hip arthroplasty
|
15 Participants
n=59 Participants
|
15 Participants
n=60 Participants
|
30 Participants
n=119 Participants
|
|
Knee arthroplasty
|
15 Participants
n=59 Participants
|
15 Participants
n=60 Participants
|
30 Participants
n=119 Participants
|
|
Adductor Canal block
|
15 Participants
n=59 Participants
|
15 Participants
n=60 Participants
|
30 Participants
n=119 Participants
|
|
Paravertebral block
|
14 Participants
n=59 Participants
|
15 Participants
n=60 Participants
|
29 Participants
n=119 Participants
|
|
Erector spinal plane block
|
0 Participants
n=59 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=119 Participants
|
|
Rectus sheath block
|
1 Participants
n=59 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=119 Participants
|
|
Transversus abdominis plane block
|
0 Participants
n=59 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=119 Participants
|
|
No peripheral nerve block
|
29 Participants
n=59 Participants
|
27 Participants
n=60 Participants
|
56 Participants
n=119 Participants
|
PRIMARY outcome
Timeframe: Mean value of the average daily pain measured on postoperative days 1, 2, 3, and 7The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily average pain scores measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
2.4 score on a scale
Standard Deviation 1.6
|
2.6 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Mean value of the worst daily pain measured on postoperative days 1, 2, 3, and 7The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the mean value of daily worst pain scores measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
4.6 score on a scale
Standard Deviation 2.0
|
4.7 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 7 (measured in oral oxycodone equivalents).
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Total OPIOID Consumption From Recovery Room Discharge Until the Data Collection Phone Call on Postoperative Day 7 (Measured in Oral Oxycodone Equivalents)
|
21 mg
Standard Deviation 24
|
17 mg
Standard Deviation 26
|
SECONDARY outcome
Timeframe: postoperative day 1The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
2.5 score on a scale
Standard Deviation 1.9
|
2.9 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: postoperative day 2The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
2.7 score on a scale
Standard Deviation 2
|
3.2 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: postoperative day 3The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
2.2 score on a scale
Standard Deviation 1.9
|
2.7 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: postoperative day 7The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
1.8 score on a scale
Standard Deviation 2
|
1.8 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: postoperative day 14The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
1.3 score on a scale
Standard Deviation 1.8
|
1 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: postoperative day 21The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
1 score on a scale
Standard Deviation 1.8
|
.7 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: postoperative day 28The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
.7 score on a scale
Standard Deviation 1.3
|
.7 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: postoperative day 180The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
0 score on a scale
Standard Deviation 0
|
.1 score on a scale
Standard Deviation .5
|
SECONDARY outcome
Timeframe: postoperative day 1The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
5.1 score on a scale
Standard Deviation 2.1
|
5.6 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: postoperative day 2The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
5.2 score on a scale
Standard Deviation 2.4
|
5.7 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: postoperative day 3The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
4.3 score on a scale
Standard Deviation 2.7
|
4.6 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: postoperative day 7The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
3.6 score on a scale
Standard Deviation 2.6
|
3.3 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: postoperative day 14The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
2.5 score on a scale
Standard Deviation 2.6
|
1.9 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: postoperative day 21The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
1.6 score on a scale
Standard Deviation 2.4
|
1.4 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: postoperative day 28The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
1.3 score on a scale
Standard Deviation 2.1
|
1.2 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: postoperative day 180The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
.3 score on a scale
Standard Deviation 1.1
|
.4 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: postoperative day 7The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
LEAST Pain Measured With the Numeric Rating Scale
|
.7 score on a scale
Standard Deviation 1.6
|
.9 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: postoperative day 14The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
LEAST Pain Measured With the Numeric Rating Scale
|
.6 score on a scale
Standard Deviation 1.2
|
.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: postoperative day 21The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
LEAST Pain Measured With the Numeric Rating Scale
|
.5 score on a scale
Standard Deviation 1.2
|
.3 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: postoperative day 28The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
LEAST Pain Measured With the Numeric Rating Scale
|
.3 score on a scale
Standard Deviation .8
|
.2 score on a scale
Standard Deviation .8
|
SECONDARY outcome
Timeframe: postoperative day 7The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
CURRENT Pain Measured With the Numeric Rating Scale
|
1.6 score on a scale
Standard Deviation 1.9
|
1.4 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: postoperative day 14The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
CURRENT Pain Measured With the Numeric Rating Scale
|
1.1 score on a scale
Standard Deviation 1.8
|
.8 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: postoperative day 21The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
CURRENT Pain Measured With the Numeric Rating Scale
|
.7 score on a scale
Standard Deviation 1.5
|
.5 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: postoperative day 28The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
CURRENT Pain Measured With the Numeric Rating Scale
|
.5 score on a scale
Standard Deviation 1
|
.4 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: postoperative day 1Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
1.3 mg
Standard Deviation 1.7
|
1 mg
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: postoperative day 2Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
1.4 mg
Standard Deviation 1.7
|
1 mg
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: postoperative day 3Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
1.1 mg
Standard Deviation 1.8
|
1.1 mg
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: postoperative day 7Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.5 mg
Standard Deviation .9
|
.7 mg
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: postoperative day 14Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.4 mg
Standard Deviation .9
|
.3 mg
Standard Deviation .9
|
SECONDARY outcome
Timeframe: postoperative day 21Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.1 mg
Standard Deviation .4
|
.2 mg
Standard Deviation .7
|
SECONDARY outcome
Timeframe: postoperative day 28Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.2 mg
Standard Deviation .9
|
.1 mg
Standard Deviation .4
|
SECONDARY outcome
Timeframe: postoperative day 180Opioid consumption of the previous 24 hours (measured in oral oxycodone equivalents)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: postoperative day 7The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference;10=complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
|
2.7 score on a scale
Standard Deviation 3.1
|
1.8 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: postoperative day 14The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference;10=complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
|
1.7 score on a scale
Standard Deviation 2.7
|
1.1 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: postoperative day 21The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference;10=complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
|
1.1 score on a scale
Standard Deviation 2.3
|
.6 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: postoperative day 28The Brief pain Inventory short form interference subscale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning using a scale of 0-70. The subscale is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference;10=complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The 7 responses for the 7 questions are totaled, producing a scale of 0-70, with 0 being preferred and 70 indicating worse functioning.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
|
.6 score on a scale
Standard Deviation 1.5
|
.3 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: postoperative day 1The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.4 events of awakening
Standard Deviation 1
|
.4 events of awakening
Standard Deviation .9
|
SECONDARY outcome
Timeframe: postoperative day 2The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.8 events of awakening
Standard Deviation 1.9
|
.6 events of awakening
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: postoperative day 3The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.4 events of awakening
Standard Deviation 1
|
.3 events of awakening
Standard Deviation .6
|
SECONDARY outcome
Timeframe: postoperative day 7The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.7 events of awakening
Standard Deviation 1.7
|
.5 events of awakening
Standard Deviation .9
|
SECONDARY outcome
Timeframe: postoperative day 14The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.8 events of awakening
Standard Deviation 1.7
|
.2 events of awakening
Standard Deviation .7
|
SECONDARY outcome
Timeframe: postoperative day 21The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.4 events of awakening
Standard Deviation 1.2
|
.1 events of awakening
Standard Deviation .4
|
SECONDARY outcome
Timeframe: postoperative day 28The number of times the participant awoke the previous night due to pain
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Awakenings Due to Pain
|
.5 events of awakening
Standard Deviation 1.2
|
.2 events of awakening
Standard Deviation .6
|
SECONDARY outcome
Timeframe: One single measure recorded on or following the day of surgery (whichever day patient is discharged)Day relative to the day of surgery that patient was discharged from the hospital (e.g., same day is postoperative day 0, while the day following surgery is postoperative day 1) over the first postoperative week. The surgical service determines when patients are to be discharged using their own criteria which are not defined by the study.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Hospitalization Duration Measured in Days
|
.3 Days
Standard Deviation .5
|
.3 Days
Standard Deviation .5
|
SECONDARY outcome
Timeframe: One measure take at the two-week postoperative check (approximately postoperative day 14)Population: This data point was not able to be collected as participants did not return to the surgeon's office for measurement at 14 days as originally anticipated
The number of degrees of passive flexion achieved from a neutral position
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One single measure recorded following the day of surgeryDay relative to the day of surgery that patient stopped using the intervention for (e.g., same day is postoperative day 0, while the day following surgery is postoperative day 1)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Day Stopped Using Intervention
|
21.3 Days
Standard Deviation 7.8
|
23.4 Days
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: queried on postoperative day 28Population: The question regarding the desirability of device use in a hypothetical future surgery was inadvertently excluded from the case report forms.
Would the patient want to use the device for a hypothetical surgery in the future (yes, no, or undecided)?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperative (within the operating room)Population: This variable was miscatagorized as an outcome measure, when it was measured PRIOR to randomization following surgery. Therefore, it is captured and reported in the baseline measurements as surgical duration.
The time of the surgical incision as recorded using military time format
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperative (within the operating room)Population: This variable was miscatagorized as an outcome measure, when it was measured PRIOR to randomization following surgery. Therefore, it is captured and reported in the baseline measurements as surgical duration.
The time of the final suture insertion as recorded using military time format
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperative (within the operating room)Population: This variable was miscatagorized as an outcome measure, when it was measured PRIOR to randomization following surgery. Therefore, it is captured and reported in the baseline measurements as surgical duration.
The time from surgical start to surgical stop measured in minutes and hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Postoperative day 1If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 2If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 3If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 7If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 14If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 21If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 28If a patient moves the anatomic location of one of the intervention devices since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With BioElectronics Model 088
n=59 Participants
Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
Active Pulsed Shortwave Treatment with BioElectronics Model 088: Application of 7-30 days of nonthermal, pulsed shortwave (radiofrequency) therapy with BioElectronics Model 088
|
Sham Treatment
n=60 Participants
Application of 7-30 days of a nonfunctional sham device.
Sham Treatment: Application of 7-30 days of a nonfunctional sham device(s)
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
Adverse Events
Active Pulsed Shortwave Treatment With BioElectronics Model 088
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Ilfeld, MD, MS
University of California San Diego
Phone: (858) 220-5714
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place