Trial Outcomes & Findings for Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain (NCT NCT01694199)
NCT ID: NCT01694199
Last Updated: 2017-05-02
Results Overview
Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.
TERMINATED
NA
139 participants
Treatment with the test device twice per day, over 3 days (7 total treatments)
2017-05-02
Participant Flow
Participant milestones
| Measure |
Active Study Device With PRFE
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
68
|
|
Overall Study
COMPLETED
|
71
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
Baseline characteristics by cohort
| Measure |
Active Study Device With PRFE
n=71 Participants
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
n=68 Participants
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 13.35 • n=7 Participants
|
45 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
68 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment with the test device twice per day, over 3 days (7 total treatments)Population: P=0.3529
Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.
Outcome measures
| Measure |
Active Study Device With PRFE
n=71 Participants
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
n=68 Participants
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
|---|---|---|
|
Overall Analgesic Efficacy (Via SPID 0-72 Hrs)
|
-244890.0 units on a scale
Interval -348835.75 to -141359.18
|
-258030.00 units on a scale
Interval -432672.7 to -172230.54
|
SECONDARY outcome
Timeframe: Treatment with the test device twice per day, over 3 days (7 total treatments)Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i)."
Outcome measures
| Measure |
Active Study Device With PRFE
n=71 Participants
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
n=68 Participants
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
|---|---|---|
|
TOTPAR-Pain Relief Experienced by Patients T0-72 Hours
|
327974.79 units on a scale
Interval 280555.32 to 375394.26
|
364873.24 units on a scale
Interval 317014.18 to 412732.29
|
SECONDARY outcome
Timeframe: Treatment with the test device twice per day, over 3 days (7 total treatments)The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.
Outcome measures
| Measure |
Active Study Device With PRFE
n=71 Participants
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
n=68 Participants
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
|---|---|---|
|
Opioid Consumption Measured in Morphine Equivalents T0-72 Hours
|
23.30 Morphine Equivalents
Interval 23.23 to 33.87
|
20.30 Morphine Equivalents
Interval 19.21 to 27.83
|
SECONDARY outcome
Timeframe: After 3 days of treatment (T0-72 hours)Number of participants who assessed pain control at 72 hours as good, very good, or excellent.
Outcome measures
| Measure |
Active Study Device With PRFE
n=71 Participants
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
n=68 Participants
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
|---|---|---|
|
Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent
|
48 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Treatment with the test device twice per day, over 3 days (7 total treatments)The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.
Outcome measures
| Measure |
Active Study Device With PRFE
n=71 Participants
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).
|
Sham Study Device With no PRFE
n=68 Participants
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity
|
|---|---|---|
|
Time to First Use of Supplemental Analgesic Medication
|
89 Minutes
Interval 70.0 to 99.0
|
87 Minutes
Interval 70.0 to 101.0
|
Adverse Events
Active Study Device With PRFE
Sham Study Device With no PRFE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place