Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05796583
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-03-20
Brief Title:
Pulsed Shortwave Therapy for Postoperative Analgesia
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Pulsed Electromagnetic Fields for Postoperative and Post-Amputation Analgesia A Randomized Participant- and Observer-Masked Sham-Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulsed shortwave radiofrequency therapy is a possible method of pain control involving the application of electromagnetic energy also termed pulsed electromagnetic fields Food and Drug Administration-cleared devices have been in clinical use for over 70 years For decades available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference making them impractical for common use However small lightweight relatively inexpensive noninvasive Food and Drug Administration-cleared devices that function for 8 days are now available to treat acute and chronic pain decrease inflammation and edema and hasten wound healing and bone regeneration Therefore it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements only without the limitations of opioids and peripheral nerve blocks The purpose of this study is to explore the possibility of treating acute postoperative pain with nonthermal pulsed shortwave radiofrequency therapy optimize the study protocol and estimate the treatment effect
Detailed Description:
The proposed study will be a randomized participant- and observer-masked sham-controlled parallel-arm human participants study with two primary aims
Specific Aim 1 To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures
Specific Aim 2 To estimate the treatment effect of adding nonthermal pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures
Hypothesis 1 primary Nonthermal pulsed shortwave therapy decreases pain in the 7 days following moderate-to-severely painful surgical procedures
Hypothesis 2 Nonthermal pulsed shortwave therapy decreases opioid use in the 7 days following moderate-to-severely painful surgical procedures
This will be a single-center University of California San Diego randomized participant- and observer-masked sham-controlled parallel-arm human subjects study
Enrollment Participants will be consenting adults undergoing various surgical procedures usually resulting in moderate-to-severe postoperative pain Study inclusion will be proposed to eligible presurgical patients If an individual desires study participation written informed consent will be obtained using a current University of California San Diego Institutional Review Board-approved informed consent form The study population of interest includes adult women and men of all races ethnicity sexual identity and socioeconomic status
Procedures Following written informed consent we will record baseline anthropometric information age sex height weight amputation details and current pain levels Participants will receive any standard peripheral nerve blocks administered using bupivacaine or ropivacaine 05 with epinephrine standard at University of California San Diego prior to undergoing their surgical procedure per standard of care
Treatment Group Assignment Each participant will be randomized to one of two treatment groups Active or Sham treatment Randomization will be stratified by surgical procedure in block sizes of 2 The computer-generated randomization lists will be created by the University of California San Diego Investigational Drug Service in a 11 treatment group ratio An Investigational Drug Service pharmacist will provide the investigators with the appropriate device Upon completion of data collection for a specific subgroup eg total knee and hip arthroplasty cholecystectomy the pharmacist will provide the investigators with a masked list of the treatment groups eg Treatment A and Treatment B and the activesham lists only following analysis for that subgroup resulting in a triple-masked study investigators participants statistician
Study intervention The pulsed shortwave device will be affixed over the primary wound areas using tape and activated prior to recovery room discharge The optimal location to treat phantom pain is currently unknown and will partially informed by the results of this study and patients will be encouraged to move the devices to a new anatomic location until relief is optimized
Supplemental analgesics In addition to the pulsed shortwave device participants will receive standard-of-care supplemental analgesics Therefore all patients of this study-regardless of the treatment arm they are randomized to-will continue to receive current usual and customary analgesia all will receive the same combination of supplemental analgesics they would regardless of study participation Participants and their caretakers will be provided with verbal and written instructions and the telephone and pager numbers of an investigator available during business hours throughout the treatment period Participants cannot shower or submerge the device as advised by the manufacturer but will be allowed to remove it to bathe and subsequently replace the device following bathing
Participants will be discharged with their pulsed shortwave device in situ and a prescription for immediate-release oral opioid preferably oxycodone 5 mg tablets taken for breakthrough pain surgeons occasionally prefer a different type of opioids such as hydrocodone which is why we analyze the data using oral oxycodone equivalents The pulsed shortwave devices will be removed by participants at home following Day 8 when the battery is exhausted Removing the devices encompasses tape removal and discarding these are disposable single-use devices
Outcome measurements end points We have selected outcome measures that have established reliability and validity with minimal inter-rater discordance and are recommended for pain-related clinical trials by the Initiative on Methods Measurement and Pain Assessment in Clinical Trials IMMPACT consensus statement All data collection will be through standard UCSD EPIC notes and patient interviews in-person during hospitalization or via a telephone call for outpatients Postoperatively surgical endpoints will be recorded such as surgical duration All pain scores will be measured using the Numeric Rating Scale 0 no pain 10 worst imaginable pain
Statistical plan and sample size estimation there will be a total of 70 surgical participants and these patients will be analyzed separately from Phase I surgical and amputation patients Sample size calculations are based upon the hypothesis that pulsed electromagnetic field therapy decreases pain in the 7 days following moderate-to-severely painful surgical procedures 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 We will use these summed scores from participants having cholecystectomy n30 and hip and knee arthroplasty n40 to estimate a probable sample size
We will consider a 33 reduction in pain scores to be the minimal clinically important difference Farrar et al J Pain Symptom Management 2003 25 406-11 Based on values from patients receiving sham in an as-of-yet unpublished pilot study we anticipate the sham group to have an anticipated mean SD of 239 123 Assuming a two-sided type I error protection of 005 and a power of 080 approximately 25 patients in each group are required ClinCalccom accessed 22323 To allow for a higher degree of variability than anticipated we will enroll a total of 70 participants cholecystectomy n30 and hip and knee arthroplasty n40
Continuous normally-distributed data will be reported as mean standard deviation Nonparametric continuous or categorical data will be reported as median 10th-90th percentiles or precents as appropriate Comparisons of independent samples will be performed using Students t-test for parametric continuous variables or Mann-Whitney U test for nonparametric or categorical variables The Chi Square test and Fishers Exact test will be used for differences in proportions as appropriate P005 will be considered statistically significant for the primary outcome Results of comparisons in secondary outcomes will be interpreted as suggestive requiring confirmation in a future trial before considering them as definitive
Specific Aim 1 To determine the feasibility and optimize the protocol for subsequent clinical trials that will compare the addition of nonthermal pulsed shortwave therapy to usual and customary analgesia following moderate-to-severely painful surgical procedures
Specific Aim 2 To estimate the treatment effect of adding nonthermal pulsed shortwave therapy to usual and customary analgesia on pain and opioid consumption following moderate-to-severely painful surgical procedures
Hypothesis 1 primary Nonthermal pulsed shortwave therapy decreases pain in the 7 days following moderate-to-severely painful surgical procedures
Hypothesis 2 Nonthermal pulsed shortwave therapy decreases opioid use in the 7 days following moderate-to-severely painful surgical procedures
This will be a single-center University of California San Diego randomized participant- and observer-masked sham-controlled parallel-arm human subjects study
Enrollment Participants will be consenting adults undergoing various surgical procedures usually resulting in moderate-to-severe postoperative pain Study inclusion will be proposed to eligible presurgical patients If an individual desires study participation written informed consent will be obtained using a current University of California San Diego Institutional Review Board-approved informed consent form The study population of interest includes adult women and men of all races ethnicity sexual identity and socioeconomic status
Procedures Following written informed consent we will record baseline anthropometric information age sex height weight amputation details and current pain levels Participants will receive any standard peripheral nerve blocks administered using bupivacaine or ropivacaine 05 with epinephrine standard at University of California San Diego prior to undergoing their surgical procedure per standard of care
Treatment Group Assignment Each participant will be randomized to one of two treatment groups Active or Sham treatment Randomization will be stratified by surgical procedure in block sizes of 2 The computer-generated randomization lists will be created by the University of California San Diego Investigational Drug Service in a 11 treatment group ratio An Investigational Drug Service pharmacist will provide the investigators with the appropriate device Upon completion of data collection for a specific subgroup eg total knee and hip arthroplasty cholecystectomy the pharmacist will provide the investigators with a masked list of the treatment groups eg Treatment A and Treatment B and the activesham lists only following analysis for that subgroup resulting in a triple-masked study investigators participants statistician
Study intervention The pulsed shortwave device will be affixed over the primary wound areas using tape and activated prior to recovery room discharge The optimal location to treat phantom pain is currently unknown and will partially informed by the results of this study and patients will be encouraged to move the devices to a new anatomic location until relief is optimized
Supplemental analgesics In addition to the pulsed shortwave device participants will receive standard-of-care supplemental analgesics Therefore all patients of this study-regardless of the treatment arm they are randomized to-will continue to receive current usual and customary analgesia all will receive the same combination of supplemental analgesics they would regardless of study participation Participants and their caretakers will be provided with verbal and written instructions and the telephone and pager numbers of an investigator available during business hours throughout the treatment period Participants cannot shower or submerge the device as advised by the manufacturer but will be allowed to remove it to bathe and subsequently replace the device following bathing
Participants will be discharged with their pulsed shortwave device in situ and a prescription for immediate-release oral opioid preferably oxycodone 5 mg tablets taken for breakthrough pain surgeons occasionally prefer a different type of opioids such as hydrocodone which is why we analyze the data using oral oxycodone equivalents The pulsed shortwave devices will be removed by participants at home following Day 8 when the battery is exhausted Removing the devices encompasses tape removal and discarding these are disposable single-use devices
Outcome measurements end points We have selected outcome measures that have established reliability and validity with minimal inter-rater discordance and are recommended for pain-related clinical trials by the Initiative on Methods Measurement and Pain Assessment in Clinical Trials IMMPACT consensus statement All data collection will be through standard UCSD EPIC notes and patient interviews in-person during hospitalization or via a telephone call for outpatients Postoperatively surgical endpoints will be recorded such as surgical duration All pain scores will be measured using the Numeric Rating Scale 0 no pain 10 worst imaginable pain
Statistical plan and sample size estimation there will be a total of 70 surgical participants and these patients will be analyzed separately from Phase I surgical and amputation patients Sample size calculations are based upon the hypothesis that pulsed electromagnetic field therapy decreases pain in the 7 days following moderate-to-severely painful surgical procedures 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 We will use these summed scores from participants having cholecystectomy n30 and hip and knee arthroplasty n40 to estimate a probable sample size
We will consider a 33 reduction in pain scores to be the minimal clinically important difference Farrar et al J Pain Symptom Management 2003 25 406-11 Based on values from patients receiving sham in an as-of-yet unpublished pilot study we anticipate the sham group to have an anticipated mean SD of 239 123 Assuming a two-sided type I error protection of 005 and a power of 080 approximately 25 patients in each group are required ClinCalccom accessed 22323 To allow for a higher degree of variability than anticipated we will enroll a total of 70 participants cholecystectomy n30 and hip and knee arthroplasty n40
Continuous normally-distributed data will be reported as mean standard deviation Nonparametric continuous or categorical data will be reported as median 10th-90th percentiles or precents as appropriate Comparisons of independent samples will be performed using Students t-test for parametric continuous variables or Mann-Whitney U test for nonparametric or categorical variables The Chi Square test and Fishers Exact test will be used for differences in proportions as appropriate P005 will be considered statistically significant for the primary outcome Results of comparisons in secondary outcomes will be interpreted as suggestive requiring confirmation in a future trial before considering them as definitive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None