Trial Outcomes & Findings for Pulsed Shortwave Therapy for Postoperative Analgesia (NCT NCT05796583)
NCT ID: NCT05796583
Last Updated: 2025-03-17
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 primary outcome calculated as follows: for each participant all of the "average" and "worst" daily pain scores collected within the first 7 postoperative days will be summed: specifically on Days 1, 2, 3, and 7, resulting in a scale of 0-80.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
First postoperative week
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 16 • n=35 Participants
|
58 years
STANDARD_DEVIATION 17 • n=35 Participants
|
55 years
STANDARD_DEVIATION 16 • n=70 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=35 Participants
|
24 Participants
n=35 Participants
|
50 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=35 Participants
|
11 Participants
n=35 Participants
|
20 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
70 participants
n=70 Participants
|
|
Height
|
165 cm
STANDARD_DEVIATION 10 • n=35 Participants
|
168 cm
STANDARD_DEVIATION 10 • n=35 Participants
|
166 cm
STANDARD_DEVIATION 10 • n=70 Participants
|
|
Weight
|
81 kg
STANDARD_DEVIATION 30 • n=35 Participants
|
87 kg
STANDARD_DEVIATION 23 • n=35 Participants
|
84 kg
STANDARD_DEVIATION 26 • n=70 Participants
|
PRIMARY outcome
Timeframe: First postoperative weekThe numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The primary outcome calculated as follows: for each participant all of the "average" and "worst" daily pain scores collected within the first 7 postoperative days will be summed: specifically on Days 1, 2, 3, and 7, resulting in a scale of 0-80.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Pain Measured With the Numeric Rating Scale
|
28 units on a scale
Standard Deviation 11
|
34 units on a scale
Standard Deviation 14
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
3.4 units on a scale
Standard Deviation 2.1
|
3.8 units on a scale
Standard Deviation 2.3
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
2.4 units on a scale
Standard Deviation 1.9
|
3.3 units on a scale
Standard Deviation 2.0
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
2.1 units on a scale
Standard Deviation 1.9
|
3.4 units on a scale
Standard Deviation 1.9
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
1.0 units on a scale
Standard Deviation 1.3
|
2.2 units on a scale
Standard Deviation 1.8
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
.9 units on a scale
Standard Deviation 1.6
|
1.4 units 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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
AVERAGE Pain Measured With the Numeric Rating Scale
|
.2 units on a scale
Standard Deviation 1.2
|
.3 units on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Median 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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Median AVERAGE Pain Measured With the Numeric Rating Scale
|
1.8 units on a scale
Interval 0.5 to 3.4
|
3.3 units on a scale
Interval 1.9 to 4.3
|
SECONDARY outcome
Timeframe: Median 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 median value of daily worst pain scores measured with the Numeric Rating Scale.
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Median WORST Pain Measured With the Numeric Rating Scale
|
5.0 units on a scale
Interval 4.0 to 5.9
|
5.5 units on a scale
Interval 3.6 to 7.1
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
6.3 units on a scale
Standard Deviation 2
|
6.8 units 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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
5.3 units on a scale
Standard Deviation 2.5
|
5.9 units on a scale
Standard Deviation 2.2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
4.7 units on a scale
Standard Deviation 2.3
|
5.1 units on a scale
Standard Deviation 2.6
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
2.7 units on a scale
Standard Deviation 1.7
|
4 units on a scale
Standard Deviation 2.5
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
2.3 units on a scale
Standard Deviation 2.1
|
2.8 units on a scale
Standard Deviation 2.6
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
WORST Pain Measured With the Numeric Rating Scale
|
.3 units on a scale
Standard Deviation 1.6
|
.6 units on a scale
Standard Deviation 1.6
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
LEAST Pain Measured With the Numeric Rating Scale
|
.4 units on a scale
Standard Deviation .9
|
.9 units on a scale
Standard Deviation 1.5
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
LEAST Pain Measured With the Numeric Rating Scale
|
.3 units on a scale
Standard Deviation .8
|
.4 units on a scale
Standard Deviation 1.3
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
CURRENT Pain Measured With the Numeric Rating Scale
|
.8 units on a scale
Standard Deviation 1.2
|
1.6 units on a scale
Standard Deviation 1.2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
CURRENT Pain Measured With the Numeric Rating Scale
|
.6 units on a scale
Standard Deviation 1.2
|
1.2 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7Cumulative opioid consumption queried on postoperative days 1, 2, 3, and 7 (measured in oral oxycodone equivalents).
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Total OPIOID Consumption for Postoperative Days 1, 2, 3, and 7 (Measured in Oral Oxycodone Equivalents)
|
4.6 mg
Standard Deviation 4.9
|
5.1 mg
Standard Deviation 7.3
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
2.1 mg
Standard Deviation 2.4
|
2 mg
Standard Deviation 3.2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
1.6 mg
Standard Deviation 2.2
|
1.4 mg
Standard Deviation 2.7
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.7 mg
Standard Deviation 1.1
|
1.2 mg
Standard Deviation 2.3
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.3 mg
Standard Deviation .9
|
.9 mg
Standard Deviation 1.7
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
.4 mg
Standard Deviation 1
|
.6 mg
Standard Deviation 1.9
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Opioid Consumption of the Previous 24 Hours (Measured in Oral Oxycodone Equivalents)
|
0.1 mg
Standard Deviation .6
|
.0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: postoperative day 7The Brief pain Inventory short form interference sub scale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning which includes 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 final scale is from 0 (no interference) to 70 (maximum interference).
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
|
9.3 score on a scale
Standard Deviation 12.4
|
12 score on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: postoperative day 14The Brief pain Inventory short form interference sub scale is an instrument specifically designed to assess pain and its impact on physical and emotional functioning which includes 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 final scale is from 0 (no interference) to 70 (maximum interference).
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Subscale)
|
6.5 score on a scale
Standard Deviation 12.6
|
9 score on a scale
Standard Deviation 13
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain
|
.7 number of awakenings
Standard Deviation 1.3
|
1.1 number of awakenings
Standard Deviation 2.2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain
|
.4 number of awakenings
Standard Deviation .8
|
.7 number of awakenings
Standard Deviation 1.2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain
|
.3 number of awakenings
Standard Deviation .9
|
1.1 number of awakenings
Standard Deviation 2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain
|
.5 number of awakenings
Standard Deviation 1.1
|
.5 number of awakenings
Standard Deviation 1.2
|
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 SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain
|
.3 number of awakenings
Standard Deviation .8
|
.9 number of awakenings
Standard Deviation 2
|
SECONDARY outcome
Timeframe: First postoperative weekDay 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)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Hospitalization Duration Measured in Days
|
.4 Days
Standard Deviation .7
|
.4 Days
Standard Deviation .7
|
SECONDARY outcome
Timeframe: intraoperative (within the operating room)The time from surgical start to surgical stop measured in minutes
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Surgical Duration
|
78 minutes
Standard Deviation 27
|
88 minutes
Standard Deviation 33
|
SECONDARY outcome
Timeframe: postoperative day 1If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: postoperative day 2If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: postoperative day 3If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: postoperative day 7If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: postoperative day 14If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last phone contact
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Device Location Changes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: postoperative day 14The number of degrees the patient can flex their knee or hip (for these procedures only; cholecystectomy excluded)
Outcome measures
| Measure |
Active Pulsed Shortwave Treatment With SofPulse
n=35 Participants
Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
Active Pulsed Shortwave Treatment: Application of 8 days of nonthermal, pulsed shortwave (radiofrequency) therapy with Endonovo Therapeutics SofPulse
|
Sham Treatment
n=35 Participants
Application of 8 days of sham device
Sham Treatment: Application of 8 days of a nonfunctional sham device
|
|---|---|---|
|
Passive Joint Flexion
|
0 Participants
|
0 Participants
|
Adverse Events
Active Pulsed Shortwave Treatment With SofPulse
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
Professor of Anesthesiology
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