Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05399355
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2022-05-19
Brief Title:
Pulsed Electromagnetic Fields for Postoperative Analgesia A Randomized Triple-Masked Sham-Controlled Pilot Study
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Pulsed Electromagnetic Fields for Postoperative Analgesia A Randomized Triple-Masked Sham-Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-07
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 electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy also termed nonthermal pulsed shortwave radiofrequency therapy 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 30 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 pilot 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 in preparation for developing subsequent definitive clinical trials
Detailed Description:
The proposed study will be a randomized participant- and observer-masked sham-controlled parallel-arm human participants pilot 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 This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials
Hypothesis 1 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 pilot 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 There are sham devices produced that are identical to active devices only they do not deliver pulsed electromagnetic energy 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 using opaque envelopes The active and sham devices are indistinguishable in appearance and therefore investigators participants and all clinical staff other than the individual who opens the randomization envelope and chooses a sham or active device will be masked to treatment group assignment for the duration of the data collection period An Investigational Drug Service pharmacist will open the envelope and provide the investigators with the appropriate device keeping all investigators masked to treatment group assignment Upon completion of data collection for a specific subgroup eg amputees total knee arthroplasty 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 2 devices if there are multiple incisions or the incision is larger than the device diameter 3 devices for total knee and hip arthroplasty or spinal surgery will be affixed over the primary wound areas using tape and activated prior to recovery room discharge Experimental The optimal location to treat phantom pain is currently unknown and will partially informed by the results of this pilot 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 devices participants will receive standard-of-care supplemental analgesics which can include acetaminophen ibuprofen ketorolac opioids gabapentin this is provider- and patient-dependent 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 can shower with the device in place but not submerge it during swimming or a bath as advised by the manufacturer
Participants will be discharged with their pulsed shortwave devices 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 30 when the battery is exhausted participants may remove them as early as Day 7 if they desire Removing the devices encompasses tape removal and discarding in the trash these are disposable single-use devices
Of note if a device is reported lost or nonfunctional during the study it will be replaced by the investigators by mail if more than 7 days of treatment remain
Study outcomes This is an exploratory pilot study to assist in planning subsequent definitive trials and we therefore have no data analysis plan We will enroll convenience samples for each of the surgical procedures of up to 30 participants for each procedure and anticipate analyzing each surgical procedure separately from the others The two outcomes of primary interest will be 1 the average and worst pain measured with the Numeric Rating Scale included in the Brief Pain Inventory pain domain and 2 opioid consumption within the first 7 postoperative days
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 This will provide an idea of the optimal surgical procedures amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials
Hypothesis 1 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 pilot 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 There are sham devices produced that are identical to active devices only they do not deliver pulsed electromagnetic energy 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 using opaque envelopes The active and sham devices are indistinguishable in appearance and therefore investigators participants and all clinical staff other than the individual who opens the randomization envelope and chooses a sham or active device will be masked to treatment group assignment for the duration of the data collection period An Investigational Drug Service pharmacist will open the envelope and provide the investigators with the appropriate device keeping all investigators masked to treatment group assignment Upon completion of data collection for a specific subgroup eg amputees total knee arthroplasty 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 2 devices if there are multiple incisions or the incision is larger than the device diameter 3 devices for total knee and hip arthroplasty or spinal surgery will be affixed over the primary wound areas using tape and activated prior to recovery room discharge Experimental The optimal location to treat phantom pain is currently unknown and will partially informed by the results of this pilot 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 devices participants will receive standard-of-care supplemental analgesics which can include acetaminophen ibuprofen ketorolac opioids gabapentin this is provider- and patient-dependent 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 can shower with the device in place but not submerge it during swimming or a bath as advised by the manufacturer
Participants will be discharged with their pulsed shortwave devices 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 30 when the battery is exhausted participants may remove them as early as Day 7 if they desire Removing the devices encompasses tape removal and discarding in the trash these are disposable single-use devices
Of note if a device is reported lost or nonfunctional during the study it will be replaced by the investigators by mail if more than 7 days of treatment remain
Study outcomes This is an exploratory pilot study to assist in planning subsequent definitive trials and we therefore have no data analysis plan We will enroll convenience samples for each of the surgical procedures of up to 30 participants for each procedure and anticipate analyzing each surgical procedure separately from the others The two outcomes of primary interest will be 1 the average and worst pain measured with the Numeric Rating Scale included in the Brief Pain Inventory pain domain and 2 opioid consumption within the first 7 postoperative days
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