Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05392803
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-05-19
Brief Title:
Pulsed Electromagnetic Fields for Post-Amputation Pain
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Pulsed Electromagnetic Fields for Post-Amputation Pain A Randomized Triple-Masked Sham-Controlled Crossover Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-09
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 chronic post-amputation 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 crossover 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 for post-amputation phantom and residual limb pain
Specific Aim 2 To estimate the treatment effect of adding nonthermal pulsed shortwave therapy to usual and customary analgesia for post-amputation phantom and residual limb pain This will provide an idea of the optimal amputee characteristics amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials
Hypothesis Nonthermal pulsed shortwave therapy will decrease pain in the 28 days following application for post-amputation pain
This will be a single-center University of California San Diego randomized participant- and observer-masked sham-controlled crossover human subjects pilot study
Enrollment Participants will be consenting adults experiencing post-amputation phantom andor residual limb pain Study inclusion will be proposed after an amputee contacts the investigators 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
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 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 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 devices used are over-the-counter Model 088 BioElectronics Frederick Maryland and 2 devices both the same treatment group will be shipped to the patient either in or out of California who will then contact an investigator for assistance in self-placement of the device on the residual limb 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 every two days until relief is experienced
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 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
Amputees will return their initial devices in pre-addressed and -stamped envelopes that we provide They will be sent a second device which is the opposite treatment of the initial device participants who initially received sham will subsequently receive active and vice versa These will be applied on approximately Day 35 and the same protocol will be repeated as for the initial device with additional data collected for 35 days after placement of the second device The second device will be discarded in the trash
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
Primary end points This is an exploratory pilot study to assist in planning subsequent definitive trials and we therefore have no data analysis plan We will enroll a convenience sample of up to 40 participants The outcome measures of primary interest will be 1 the change in average residual and phantom limb pain scores between baseline and Day 28 of the initial treatment as well as 2 the Patient Global Impression of Change on Day 28 of the initial treatment
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 for post-amputation phantom and residual limb pain
Specific Aim 2 To estimate the treatment effect of adding nonthermal pulsed shortwave therapy to usual and customary analgesia for post-amputation phantom and residual limb pain This will provide an idea of the optimal amputee characteristics amenable to this analgesic technique and allow determination of the required sample sizes of subsequent definitive clinical trials
Hypothesis Nonthermal pulsed shortwave therapy will decrease pain in the 28 days following application for post-amputation pain
This will be a single-center University of California San Diego randomized participant- and observer-masked sham-controlled crossover human subjects pilot study
Enrollment Participants will be consenting adults experiencing post-amputation phantom andor residual limb pain Study inclusion will be proposed after an amputee contacts the investigators 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
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 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 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 devices used are over-the-counter Model 088 BioElectronics Frederick Maryland and 2 devices both the same treatment group will be shipped to the patient either in or out of California who will then contact an investigator for assistance in self-placement of the device on the residual limb 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 every two days until relief is experienced
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 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
Amputees will return their initial devices in pre-addressed and -stamped envelopes that we provide They will be sent a second device which is the opposite treatment of the initial device participants who initially received sham will subsequently receive active and vice versa These will be applied on approximately Day 35 and the same protocol will be repeated as for the initial device with additional data collected for 35 days after placement of the second device The second device will be discarded in the trash
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
Primary end points This is an exploratory pilot study to assist in planning subsequent definitive trials and we therefore have no data analysis plan We will enroll a convenience sample of up to 40 participants The outcome measures of primary interest will be 1 the change in average residual and phantom limb pain scores between baseline and Day 28 of the initial treatment as well as 2 the Patient Global Impression of Change on Day 28 of the initial treatment
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