Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
|ClinicalTrials.gov Identifier: NCT01694199|
Recruitment Status : Terminated (IDMC recommendation)
First Posted : September 27, 2012
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain||Device: Pulsed Radiofrequency Energy (PRFE) Device: No Pulsed Radiofrequency Energy (PRFE)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Sham-Controlled, Double-Blinded Study to Evaluate the Analgesic Efficacy and Safety of Pulsed Radiofrequency Energy (PRFE) in Bunionectomy Surgery for the Treatment of Post-Operative Pain|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Active study device with PRFE
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Device: Pulsed Radiofrequency Energy (PRFE)
The intervention is pulsed radiofrequencyenergy (PRFE).
Other Name: Provant Therapy System
Sham Comparator: Sham study device with no PRFE
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
Device: No Pulsed Radiofrequency Energy (PRFE)
Sham (placebo) with no therapeutic device activity
Other Name: Sham Provant Therapy System
- Overall Analgesic Efficacy (Via SPID 0-72 Hrs) [ Time Frame: Treatment with the test device twice per day, over 3 days (7 total treatments) ]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.
- TOTPAR-Pain Relief Experienced by Patients T0-72 Hours [ Time Frame: 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)."
- Opioid Consumption Measured in Morphine Equivalents T0-72 Hours [ Time Frame: 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.
- Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent [ Time Frame: After 3 days of treatment (T0-72 hours) ]Number of participants who assessed pain control at 72 hours as good, very good, or excellent.
- Time to First Use of Supplemental Analgesic Medication [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694199
|United States, California|
|Lotus Clinical Research|
|Pasadena, California, United States, 91105|
|United States, Maryland|
|Chesapeake Research Group|
|Pasadena, Maryland, United States, 21122|
|United States, Texas|
|Endeavor Clinical Trials|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Neil K. Singla, MD||Lotus Clinical Research, LLC|