Pulsed Electromagnetic Fields for Postoperative and Post-Amputation Analgesia: A Randomized, Participant- and Observer-Masked, Sham-Controlled Pilot Study
Phase: NA
Conditions: Postoperative Pain, Acute
Sponsor: University of California, San Diego

Official Title:  Pulsed Electromagnetic Fields for Postoperative 
and Post-Amputation Analgesia:  A Randomized, Participant- and 
Observer-Masked, Sham-Controlled Pilot Study 
 
 
 
NCT:  05796583 
 
 
 
Document date:  February 23, 2023 
 

 
 
 
UCSD Human Research Protections Program 
New Biomedical Application 
RESEARCH PLAN 
Instructions for completing the Research Plan are available on the HRPP website. 
The headings on this set of instructions correspond to the headings of the Research Plan. 
General Instructions: Enter a response for all topic headings.  
Enter “Not Applicable” rather than leaving an item blank if the item does not apply to this project. 
Version date: 9/30/2013 
1. 
PROJECT TITLE 
Pulsed Electromagnetic Fields for Postoperative and Post-Amputation Analgesia:   
A Randomized, Participant- and Observer-Masked, Sham-Controlled Pilot Study 
 
2. 
PRINCIPAL INVESTIGATOR  
Brian Ilfeld, MD, MS 
 
3. 
FACILITIES 
UCSD health system:  Thornton Hospital, Jacobs Medical Center, Hillcrest Medical Center, KOP 
Amputees will self-administer the intervention in their homes in any of the 50 States of the U.S. 
 
4. 
ESTIMATED DURATION OF THE STUDY 
Three years (1 month preparation, 24 months enrollment, 11 months publication prior to closure) 
 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS (no more than one paragraph) 
The moderate-to-severe pain many patients experience following surgery is often treated with 
opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory 
depression (and a risk of abuse, dependence, and diversion).  Potent site-specific analgesia with 
fewer side effects may be provided with peripheral nerve blocks.  However, these too have limitations 
such as a duration of action measured in hours, while the pain from surgery is usually measured in 
days or weeks.  Pulsed electromagnetic field therapy is an alternative method of pain control 
involving the application of electromagnetic energy.  FDA-cleared devices have been in clinical use 
for over 70 years, demonstrating an extraordinary safety profile:  these are noninvasive and non-
pharmacologic devices, with no side effects, adverse events, or medication interactions; and the only 
contraindications are pregnancy and an implanted pulse generator such as a cardiac pacemaker.  
The device has no potential for dependence, abuse, or diversion.  Until relatively recently, 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, FDA-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 following surgery, 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 and chronic post-amputation pain with pulsed 
electromagnetic field therapy, optimize the study protocol, and estimate the treatment effect in 
preparation for developing subsequent definitive clinical trials. 
 
6. 
SPECIFIC AIMS 
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 pulsed electromagnetic field therapy to usual and customary 

 
 
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analgesia following moderate-to-severely painful surgical procedures or post-amputation 
phantom and residual limb pain. 
 
Specific Aim 2:  To estimate the treatment effect of adding pulsed electromagnetic field therapy to 
usual and customary analgesia on pain and opioid consumption following moderate-to-severely 
painful surgical procedures or post-amputation phantom and residual limb pain.  This will provide 
an idea of the optimal surgical procedures and amputee characteristics amenable to this 
analgesic technique and allow determination of the required sample sizes of subsequent 
definitive clinical trials. 
 
Hypothesis 1:  Pulsed electromagnetic field therapy decreases pain in the 7 days following 
moderate-to-severely painful surgical procedures or 28 days following application for post-
amputation pain. 
 
Hypothesis 2:  Pulsed electromagnetic field therapy decreases opioid use in the 7 days following 
moderate-to-severely painful surgical procedures. 
 
 
7. 
BACKGROUND AND SIGNIFICANCE 
The moderate-to-severe pain many patients experience following surgery is often treated with 
opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory 
depression (and a risk of abuse, dependence, and diversion).  Potent site-specific analgesia with 
fewer side effects may be provided with peripheral nerve blocks.  However, these too have limitations 
such as requiring an anesthesiologist for administration, a duration of action measured in hours, and 
rendering the target area/limb insensate. 
 
An analgesic alternative with few associated limitations is pulsed electromagnetic field (PEMF) 
therapy, also called pulsed short-wave therapy, pulsed radiofrequency energy therapy, and 
radiofrequency nonthermal diathermy.1  Over the last 7 decades, PEMF has been used to treat acute 
and chronic pain, decrease inflammation and edema, and hasten wound healing and bone 
regeneration.1  Possible mechanisms for the multiple clinical effects of PEMF are multifactorial, 
complex, and only partially understood.1  The primary theory involves the promotion of calcium 
binding to calmodulin which activates endothelial and neuronal nitric oxide synthase isoforms, 
producing nitric oxide which has anti-inflammatory and analgesic effects, among other consequences 
such as decreasing edema while increasing blood and lymph flow.1 
 
In 1947, the United States Federal Communications Commission 
assigned three frequencies for radiofrequency use in medical 
treatments:  40.68, 13.56 and 27.12 MHz.1  Within just a few years, the 
first pulsed electromagnetic field generator was cleared by the United 
States Food and Drug Administration for use with patients using 27.12 
MHz:  the Diapulse.2,3.  Until relatively recently, 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 (Figure, right).  However, 
over the past 70 years they have exhibited an extraordinary safety 
profile:  these are noninvasive, nonpharmacologic devices, with no side 
effects, adverse events, or medication interactions; and the only 

 
 
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contraindications are pregnancy and an implanted pulse generator such as a cardiac pacemaker.  
Unlike opioids, there is no risk of abuse, dependence, and/or diversion. 
 
More recently, small, simple, lightweight, battery-powered, noninvasive PEMF devices have received 
FDA clearance for use treating acute and chronic pain, including the ActiPatch and RecoveryRx for 
amputees and the initial 150 surgical subjects of Phase I (Model 088, BioElectronics, Frederick, 
Maryland; Figure, below left); as well as SofPulse for the subsequent 80 surgical subjects of Phase 
II (Endonovo Therapeutics, Woodland Hills, California; Figure below right).  We will be using the 
devices for FDA-approved indications; in other words, on-label use. 
 
 
 
 
 
First described as a therapy to treat postoperative pain in the 1960s,4 multiple investigations suggest 
analgesic benefits following various types of surgical procedures, including breast reduction,5 
reconstruction,6 and augmentation;1,7 anterior cruciate ligament reconstruction;8 molar extraction;9 
and cesarean section.10  Chronic pain conditions have also been treated with PEMF therapy, 
including knee osteoarthritis and failed back surgery syndrome.11,12  However, PEMF has not found 
widespread use, probably due to the cost and size of the initial large console devices; and later 
lacking credibility due to scant randomized data.  What studies have been published generally 
involve small sample sizes,1,5,7 lack a control group,13 lack prospective registration,10 and/or authors 
with a significant conflict-of-interest.1,8,14-19 
 
Nevertheless, there appears to be extraordinary unrealized potential for PEMF to treat acute and 
chronic pain:  it can be easily applied in less than one minute by a layperson using tape, induces no 
side effects (it induces no perceptible sensations at all), is completely noninvasive, is lighter and 

 
 
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thinner than many surgical bandages, may be applied to nearly any part of the body, functions 
through clothing or bandages, has only two contraindications (pregnancy and an implanted pulse 
generator), requires no intervention by patient or provider, has a duration of up to 30 days (unlimited 
duration using serial devices), has not resulted in any adverse events, has no 
abuse/dependence/diversion potential, and is relatively inexpensive compared to most other 
analgesics.  Due to its demonstrated benign profile and relatively low cost, PEMF could be 
applicable to nearly every painful surgical procedure and chronic pain condition, similar to 
acetaminophen and NSAIDs (only without every 6-hour patient/provider administration and the 
potential toxicity of acetaminophen and side effects/complications of NSAIDs). 
 
Consequently, we propose a randomized, participant- and observer-masked, sham-controlled, 
parallel-arm clinical pilot study to demonstrate feasibility and optimize the protocol as well as 
estimate the treatment effect to help design and power subsequent definitive, multicenter, 
randomized, controlled clinical trials.  The primary hypotheses are that PEMF decreases pain 
(and opioids for surgical patients) in the 7 days following moderate-to-severely painful 
surgical procedures or 28 days following application for post-amputation pain. 
 
8. 
PROGRESS REPORT 
N/A 
 
9. 
RESEARCH DESIGN AND METHODS 
This will be a single-center (UCSD), randomized, participant- and observer-masked, sham-controlled, 
parallel-arm human subjects pilot study. 
 
Enrollment.  Participants will be consenting adults either (1) undergoing various surgical procedures 
usually resulting in moderate-to-severe postoperative pain, or (2) experience post-amputation 
phantom and/or residual limb pain.  Study inclusion will be proposed (1) to eligible presurgical 
patients or (2) after an amputee contacts the investigators.  If an individual desires study 
participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF.  
The study population of interest includes adult women and men of all races, ethnicity, sexual identity, 
and socioeconomic status.  Inclusion and exclusion criteria are listed in section #10 below. 
 
Procedures.  Following written, informed consent, we will record baseline anthropometric information 
(age, sex, height, weight, amputation details and current pain levels).  Surgical participants will 
receive any standard peripheral nerve block(s) administered using bupivacaine or ropivacaine 0.5% 
with epinephrine (standard at UCSD) 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.  For the initial 150 subjects of Phase I, there are sham RecoveryRx 
devices produced that are identical to active RecoveryRx devices, only they do not deliver PEMF.  
Randomization will be stratified by surgical procedure/amputation, 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 1:1 treatment group ratio using opaque envelopes.  For the initial 150 subjects of 
Phase I using RecoveryRx devices, 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.  For the subsequent 80 

 
 
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subjects of Phase II, active SofPulse devices will be provided to patients randomized to the active 
treatment group; and sham RecoveryRx devices will be provided to the patients randomized to the 
sham treatment group. 
 
Study intervention.  For surgical patients of Phase I, the PEMF 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 area(s) using tape and activated 
prior to recovery room discharge (Experimental).  For surgical patients of Phase II, a single PEMF 
device will be used for each participant due to their larger diameter and treatment area.  For 
amputees, the device used is over-the-counter (ActiPatch, 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 PEMF device(s), 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 (of note, amputees will be asked to continue their normal analgesic regimen, 
including any as-needed treatments).  Participants (and their caretakers of surgical patients) 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. 
 
Surgical participants will be discharged with their PEMF device(s) 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 PEMF devices will be removed by 
participants at home following Day 8 (SofPulse) or Day 30 (Actipatch/RecoveryRx) 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). 
 
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 
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. 
 
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 

 
 
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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).  On 
Days 35 and 70, amputees will be asked if they would want to continue using the device; and on Day 
28 surgical patients will be asked if they would want to use the device if they were to have the same 
surgery in the future?  For Phase II surgical participants, Days 21 and 28 will be excluded due to the 
shorter treatment period (8 days) of this device relative to that used in Phase I.  At all time points for 
amputees, phantom and residual limb pain will be distinguished and recorded separately. 
 
Summary of post-enrollment assessments (color added for clarity) 
Time Point: 
Surgical Patients 
Postoperative Days 
Amputees 
Post-Application Days 
1 
2 
3 
7 
14 21 28 180 
0 
2 
4 
7 
21 
28 
35 
Opioid consumption 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
Average Pain [NRS] 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
Worst Pain [NRS] 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
Brief Pain Inventory, 
Short Form 
 
 
 
• 
• 
• 
• 
 
• 
 
 
 
 
• 
• 
Patient Global 
Impression Change 
 
 
 
 
 
 
 
 
 
• 
• 
• 
• 
• 
• 
Sleep disturbances 
(#) previous night 
• 
• 
• 
• 
• 
• 
• 
 
• 
• 
• 
• 
• 
• 
• 
Passive flexion 
(knees and hips) 
 
 
 
 
• 
 
 
 
 
 
 
 
 
 
 
 
Primary end points:  This is an exploratory pilot study to assist in planning subsequent definitive 
trials and we therefore have no data analysis plan.  For surgical patients, 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.  For amputees, 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. 
 
For Phase II, 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 (n=30), and hip and knee arthroplasty (n=40) to estimate a probable sample size. 
 

 
 
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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 Phase I, we anticipate the sham group to have an anticipated mean (SD) of 23.9 
(12.3).  Assuming a two-sided type I error protection of 0.05 and a power of 0.80, approximately 25 
patients in each group are required (ClinCalc.com, accessed 2/23/23).  To allow for a higher degree 
of variability than anticipated we will enroll a total of 70 participants in Phase II:  cholecystectomy 
(n=30), and hip and knee arthroplasty (n=40). 
 
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 Student’s t-test for 
parametric continuous variables or Mann-Whitney U test for nonparametric or categorical variables.  
The Chi Square test and Fisher’s Exact test will be used for differences in proportions, as 
appropriate.  P<0.05 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. 
 
 
10. 
HUMAN PARTICIPANTS 
We will recruit a convenience sample with a maximum of 270 participants in total (all participants 
who sign an informed consent included).  Selection for inclusion will not be based on race, 
ethnicity, sexual identity, or socioeconomic status.  There will be no participants from vulnerable 
populations, such as pregnant women, children, or prisoners. 
 
Inclusion criteria (amputees):  Adult patients of at least 18 years of age [19 years in Alabama and 
Nebraska], (1) with an upper or lower limb amputation at least 12 weeks prior to enrollment distal to 
the shoulder or hip (femoral head remaining), respectively, and including at least one metacarpal or 
metatarsal bone, respectively; (2) who experience at least moderate residual and/or phantom limb 
pain—defined as a 3 or higher on the Numeric Rating Scale (NRS; 0-10, 0= no pain; 10=worst 
imaginable pain)—at least daily for the previous 2 months; and (3) willing to avoid both changes to 
their analgesic regimen as well as elective surgical procedures for 70 days after initiation of treatment 
with PEMF therapy. 
 
Inclusion criteria (surgical patients):  Adult patients of at least 18 years of age undergoing one of 
the surgical procedures listed below: 
 
a.  non-mastectomy breast surgery with a single-injection paravertebral nerve block 
b.  laparoscopic or open cholecystectomy 
c.  laparoscopic sleeve gastrectomy 
d.  percutaneous nephrolithotomy 
e.  ventral hernia repair  
f.   inguinal hernia repair 
g.  knee or hip arthroplasty 
h.  foot/ankle surgery with at least moderate pain anticipated 
i.   shoulder acromioclavicular joint repair, labral repair, subacromial decompression, or 
Bankart repair (without rotator cuff repair) 
j.   hand/forearm/elbow/shoulder surgery with at least moderate pain anticipated 
k.  spinal surgery with at least moderate pain anticipated 

 
 
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Exclusion criteria: (1) concurrent use of an implanted pulse generator (e.g., cardiac pacemaker); (2) 
pregnancy; (3) incarceration.  Surgical participants only:  (4) chronic opioid/tramadol use (daily use 
within the 2 weeks prior to surgery and duration of use > 4 weeks); (5) neuro-muscular deficit of the 
surgical area/limb; (6) a planned postoperative perineural local anesthetic infusion. 
 
11. 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
Amputees.  The Primary Investigator will place Institutional Review Board-approved study 
advertisements within print and web-based publications that are frequently read by the target 
population.  Additionally, site directors will provide similar Institutional Review Board-approved 
advertising material to the leaders of local and regional amputee focus/support groups.  Individuals 
who are interested in the study will be directed to contact the study investigators or research 
coordinators for a thorough description of the study purpose and protocol.  Finally, chronic pain 
physicians will be provided with the IRB-approved advertisements to give to their patients with an 
amputation and chronic pain. 
 
Individuals interested in the study will contact a research coordinator or investigator by email or 
telephone (contact information provided in the IRB-approved advertisements).  Patients meeting 
inclusion and exclusion criteria will be presented with the study and provided the IRB-approved ICF 
and HIPAA consent electronically for their review.  Individuals wishing to participate will have the 
option to (1) print the IRB-approved consent forms, sign the forms, and return them via the postal 
service; or (2) have UCSD send them the consent forms via a postal service, of which they may then 
sign and return in pre-addressed and stamped envelopes provided in the original envelope.  
Following receipt of the signed consent forms, participants will be randomized and sent an active or 
sham PEMF device by a postal service with instructions to contact the investigative team upon arrival 
for assistance in applying the device. 
 
 
Surgical participants.  The investigators will need to know in advance which patients would like to 
participate in order to have a research coordinator present on the day of surgery.  The investigators 
therefore need to contact potential participants prior to their pre-surgery visit and request a partial 
waiver of HIPAA authorization for recruitment purposes.  We will scan the upcoming surgery 
schedule (which we have access to being anesthesiologists—we use this schedule daily for medical 
purposes), identify patients having the types of surgical procedures specified for this study, look in 
their electronic records to determine eligibility, and if eligible either call the potential participants 
ourselves or provide the name and contact information to a research coordinator to contact the 
potential participants. 
 
1.  These procedures are minimal risk to the potential participants as we are anesthesiologists who 
will be viewing these records even without study participation in preparation for surgery and 
postoperative analgesia planning.  There is no information that an anesthesiologist would not view 
regardless of the existence of the study. 
 
2.  A partial waiver of HIPAA authorization for recruitment purposes would not adversely affect the 
rights and welfare of the potential participants as we are anesthesiologists who will be viewing these 
records even without study participation in preparation for surgery and postoperative analgesia 

 
 
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planning.  There is no information that an anesthesiologist would not view regardless of the existence 
of the study. 
 
3.  This clinical trial could not be practicably carried out without the partial waiver because many 
relatively healthy ambulatory patients are not seen in preop clinic; or they are seen just 1-2 days prior 
to their date of surgery.  The investigators will need to know in advance which patients would like to 
participate in order to have a research coordinator present on the day of surgery. 
 
4.  After participants are contacted, if they would like to participate, they will receive written, informed 
consent using an IRB-approved informed consent form. 
 
These procedures would also include access to PHI: 
 
1.  Identifiers will include the potential participant’s date of surgery, surgeon, name, phone number, 
and email address (to send ICF if patient is interested in participation).  This information will be 
recorded in hard-copy format and destroyed using a paper shredder (or in the locked UCSD PHI 
disposal stations) following contact with the patient.  If the patient does not participate, then there will 
be no record of PHI whatsoever.  If the patient does participate, then PHI will be protected as 
described in #16 below. 
 
2.  This clinical trial could not be practicably carried out without the partial waiver because many 
relatively healthy ambulatory patients are not seen in preop clinic; or they are seen just 1-2 days prior 
to their date of surgery.  We need to schedule a research coordinator to be present for the day of 
surgery. 
 
3.  The privacy risk to individuals whose PHI will be used is minimal since, as anesthesiologists at 
UCSD caring for ambulatory surgery patients, we use the surgery schedule daily in the normal 
course of our work caring for patients; and we will not record any PHI other than date of surgery, 
surgeon, name, contact phone numbers, and email address—and these will be destroyed following 
use.  The anticipated benefit to participants is a chance of improving their postoperative pain control 
if they are randomized to active stimulation. 
 
4.  PHI that will be used includes date of surgery, surgeon, name, contact phone numbers, email 
address, basic anthropometric data such as height and weight, past medical and surgical history, and 
the surgical schedule itself.  Only coinvestigators will access this PHI, and the only people they might 
share it with are research coordinators actively participating in this research who understand PHI 
procedures and to appropriately destroy the hard copy of date/surgeon/name/contact numbers/email 
address after use. 
 
Patients meeting inclusion and exclusion criteria will be presented with the study, and prospective 
study participants desiring additional information will be required to give permission for a research 
coordinator to contact them to adhere to HIPAA requirements.  The study protocol will be reviewed 
with interested prospective participants in detail; and for participants desiring participation, written, 
informed consent will be obtained prior to any measurements, data collection, and/or interventions.  
The method of documenting consent will be using written informed consent forms approved by the 
local Institutional Review Board. 
 
12. 
INFORMED CONSENT 

 
 
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Amputees.  Individuals interested in the study will contact a research coordinator or investigator by 
email or telephone (contact information provided in the IRB-approved advertisements).  Patients 
meeting inclusion and exclusion criteria will be presented with the study and provided the IRB-
approved ICF and HIPAA consent electronically for their review.  Individuals wishing to participate will 
have the option to (1) print the IRB-approved consent forms, sign the forms, and return them via the 
U.S. Postal Service; or (2) have UCSD send them the consent forms via the U.S. Postal Service, of 
which they may then sign and return in pre-addressed and stamped envelopes provided in the 
original envelope.  Following receipt of the signed consent forms, participants will be randomized and 
sent an active or sham PEMF device by U.S. Postal Service with instructions to contact the 
investigative team upon arrival for assistance in applying the device. 
 
Surgical participants.  Candidates who meet inclusion and exclusion criteria and desire study 
enrollment will be scheduled to arrive the day of surgery 15 minutes earlier than normal to allow for 
written informed consent and baseline information collection.  Written informed consent will be 
attained prior to any measurements or procedures prior to surgery.  When participants present for 
surgery, research coordinators will provide and attain written informed consent.  This will occur in 
private patient care areas, so that participants may feel comfortable asking questions of the research 
coordinator. 
We do not foresee any issues relevant to the mental capacity of the potential human participants.  
Written, informed consent will be attained prior to any study procedures or measurements; and 
participants will not receive procedure-related sedation until following the written, informed consent 
process is completed.  Participants will be provided privacy and time for decision making both in the 
study description/explanation telephone call to an investigator or research coordinator, as described 
above; and, the morning of the initial treatment using a private patient care area to again review the 
study, informed consent form, and answer any remaining questions.  As noted previously, 
participants may speak with an investigator by telephone from initial contact through the morning of 
treatment; and will have access during and following the treatment(s) with cellular phone and pager 
numbers provided upon discharge. 
This study protocol has follow-up data-collection telephone calls a maximum of 6 months following 
the initial study treatment (70 days for amputees), so repeated informed consent following the initial 
consent is unnecessary, as opposed to multi-year, longer-term clinical trials.  Surrogate consent will 
not be accepted; therefore, if human participants cannot provide consent on their own, they will not 
be offered study enrollment.  Consent by an individual’s Legally Authorized Representative is 
unacceptable for study enrollment. 
Following informed consent and the signing of the UCSD IRB-approved ICF and HIPAA documents, 
these documents will be copied, and the copy placed in the patient’s medical record.  The participant 
will be provided a copy along with the Participants’ Bill of Rights. 
 
13. 
ALTERNATIVES TO STUDY PARTICIPATION 
Patients can decline enrollment.  For amputees, their current analgesic regimen will not deviate due 
to inquiry regarding the study.  For surgical patients, they will still receive the standard-of-care 
postoperative analgesia. 
 
14. 
POTENTIAL RISKS 

 
 
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There are currently no known medical risks from PEMF, although there is the risk of an allergic 
reaction to the tape used to hold the device to the skin.  There is the risk of loss of confidentiality.  
The following study procedures will be done to maintain confidentiality of this study:  hard copies will 
be kept in locked medical offices and the locked Investigational Drug Service’s files.  Any digitized 
records containing personal health information will be stored as password-protected and encrypted 
files. 
 
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
There are only two medical contraindications to PEMF:  pregnancy and use within 6” of an 
implantable pulse generator.  There is no known theoretical risk to a developing fetus; but since this 
has not been studied, pregnancy is avoided out of an abundance of caution.  Modern implanted pulse 
generators such as cardiac pacemakers are shielded from PEMF, so keeping the PEMF device at 
least 6” from a pacemaker is also out of an abundance of caution as even a PEMF device placed 
directly over a pacemaker should have no effect on the pacemaker function.  All patients undergoing 
surgery will have a pregnancy test as part of their regular care, regardless of study participation.  
Amputees will be placing the devices on their limb, and the only portion of the body that receives 
radiofrequency energy is within the ring of the device which will not be applied to the pelvis or lower 
abdomen in these patients.  Regarding implantable pulse generators, there is theoretically no risk in 
using PEMF therapy as modern generators are shielded from such energy.  However, out of an 
abundance of caution, we will not include any patients with an implanted pulse generator. 
 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT 
The following study procedures will be done to maintain confidentiality of this study:  hard copies will 
be kept in a locked medical office. Only the investigators will have access to the records.  Any 
electronic records with patient identifiers will be password protected according to UCSD IT 
recommendations and policies.  No patient identifiers will be used in reporting data from the study.  
Every effort will be made to assure protection of patient privacy.  The data will not be shared with the 
manufacturer. 
 
This study will require access to the medical record of patients who have consented to participate as 
participants.  The privacy of these patients will be protected in the manner described below: 
1. Specific consent will be obtained from each patient to permit examination of his or her medical 
record.  
2. Information obtained during the study will be de-identified with study specific identifiers that do 
not permit recognition of any participants’ personal information.  
3. All information gathered will be stored in a locked cabinet which is inside a locked room which 
will be accessible only to registered study investigators.   
4. Any data gathered stored on portable electronic media (e.g. flash drives) will be stored in this 
cabinet when not in use. 
5. Any digitized records will be stored in encrypted files on password-protected computers. 
6. No photographs will be taken. 
 
17. POTENTIAL BENEFITS 
For participants randomized to receive sham:  There will be no difference between being in this 
study and “standard” care.  However, for amputees who receive a sham device initially, they will 
subsequently receive an active device and therefore this will not apply. 
 

 
 
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For participants randomized to receive active stimulation:  It is our hope that patients have 
decreased pain, opioid consumption, sleep disturbances, and pain-induced physical and emotional 
dysfunction. 
 
Possible benefits to others:  Future patients may benefit if it is determined that PEMF therapy 
decreases postamputation and postoperative pain, as well as opioid requirements.  Finding an 
effective non-opioid analgesic would be a tremendous step forward in helping future patients. 
 
18. RISK/BENEFIT RATIO 
There are no known medical risks of PEMF therapy, although there is the risk of allergic reaction 
from the tape used to secure the device to the skin.  With its ease of application, lack of side effects, 
prolonged duration of action, and simple removal, PEMF therapy has the very real possibility of 
replacing opioid analgesics—the standard of care for the past 100 years—that would completely 
revolutionize postoperative analgesia, as we know it. 
 
19. EXPENSE TO PARTICIPANT 
None 
 
20. COMPENSATION FOR PARTICIPATION 
None 
 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
Principal Investigator and Co-investigators are board-certified anesthesiologists with fellowship 
training in regional anesthesia and acute pain who place peripheral nerve blocks and manage acute 
pain on a regular basis.  All hold a license to practice medicine in California, have medical privileges 
at the UC Medical Centers, and will be responsible for the overall management of this study. 
 
Investigators:  Brian Ilfeld, MD, MS; John Finneran, MD; and Engy Said, MD. 
 
Baharin Abdullah is the current Program Manager of the Division of Regional Anesthesia and Acute 
Pain Medicine, and will therefore be performing regulatory work, consenting participants, mailing 
potential and enrolled participants, interacting with participants, and collecting data. 
 
22. BIBLIOGRAPHY 
 
1. Rawe IM, Lowenstein A, Barcelo CR, Genecov DG: Control of postoperative pain with a wearable 
continuously operating pulsed radiofrequency energy device: a preliminary study. Aesthetic Plast 
Surg 2012; 36: 458-63 
2. Steinberg MD: Diapulse Therapy in General Podiatry Practice, a Preliminary Report. J Am 
Podiatry Assoc 1964; 54: 849-52 
3. Cameron BM: A Three Phase Evaluation of Pulsed, High Frequency, Radio Short Waves 
(Diapulse): 646 Patients. Am J Orthop 1964; 6: 72-8 
4. Kaplan EG, Weinstock RE: Clinical evaluation of diapulse as adjunctive therapy following foot 
surgery. J Am Podiatry Assoc 1968; 58: 218-21 
5. Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA: Effects of pulsed electromagnetic fields on 
interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast 
reduction patients. Plast Reconstr Surg 2010; 125: 1620-9 

 
 
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6. Rohde CH, Taylor EM, Alonso A, Ascherman JA, Hardy KL, Pilla AA: Pulsed Electromagnetic 
Fields Reduce Postoperative Interleukin-1beta, Pain, and Inflammation: A Double-Blind, Placebo-
Controlled Study in TRAM Flap Breast Reconstruction Patients. Plast Reconstr Surg 2015; 135: 
808e-817e 
7. Heden P, Pilla AA: Effects of pulsed electromagnetic fields on postoperative pain: a double-blind 
randomized pilot study in breast augmentation patients. Aesthetic Plast Surg 2008; 32: 660-6 
8. Benazzo F, Zanon G, Pederzini L, Modonesi F, Cardile C, Falez F, Ciolli L, La Cava F, Giannini 
S, Buda R, Setti S, Caruso G, Massari L: Effects of biophysical stimulation in patients undergoing 
arthroscopic reconstruction of anterior cruciate ligament: prospective, randomized and double 
blind study. Knee Surg Sports Traumatol Arthrosc 2008; 16: 595-601 
9. Stocchero M, Gobbato L, De Biagi M, Bressan E, Sivolella S: Pulsed electromagnetic fields for 
postoperative pain: a randomized controlled clinical trial in patients undergoing mandibular third 
molar extraction. Oral Surg Oral Med Oral Pathol Oral Radiol 2015; 119: 293-300 
10. Khooshideh M, Latifi Rostami SS, Sheikh M, Ghorbani Yekta B, Shahriari A: Pulsed 
Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean 
Section: A Randomized, Double-Blind, Placebo-controlled Trial. Clin J Pain 2017; 33: 142-147 
11. Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF: Pulsed electromagnetic fields in knee 
osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford) 
2016; 55: 755-62 
12. Harper WL, Schmidt WK, Kubat NJ, Isenberg RA: An open-label pilot study of pulsed 
electromagnetic field therapy in the treatment of failed back surgery syndrome pain. Int Med Case 
Rep J 2015; 8: 13-22 
13. Nicolle FV, Bentall RM: Use of radio-frequency pulsed energy in the control of postoperative 
reaction in blepharoplasty. Aesthetic Plast Surg 1982; 6: 169-71 
14. Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA: Evidence-based use of pulsed 
electromagnetic field therapy in clinical plastic surgery. Aesthet Surg J 2009; 29: 135-43 
15. Koneru SN, Staelin R, Rawe IM: Chronic pain intervention using pulsed shortwave therapy: the 
relationship between pain demographics and central sensitization inventory. Pain Manag 2019; 9: 
283-296 
16. Staelin R, Koneru SN, Rawe IM: An over-the-counter central sensitization therapy: a chronic back 
pain registry study of pain relief, medication use and their adverse effects. Pain Manag 2017; 7: 
99-111 
17. Staelin R, Koneru SN, Rawe IM: A Prospective Six-Month Study of Chronic Pain Sufferers: A 
Novel OTC Neuromodulation Therapy. Pain Res Manag 2019; 2019: 3154194 
18. Brook J, Dauphinee DM, Korpinen J, Rawe IM: Pulsed radiofrequency electromagnetic field 
therapy: a potential novel treatment of plantar fasciitis. J Foot Ankle Surg 2012; 51: 312-6 
19. El Mohammad AR, Koneru SN, Staelin R, McLeod K, Tabbouche O, Rawe IM: Pulsed shortwave 
therapy in cervical osteoarthritis: An NSAID-controlled, randomized clinical trial. SN 
Comprehensive Clinical Medicine 2021; 3: 166-75 
 
 
23. FUNDING SUPPORT FOR THIS STUDY 
Departmental funding and PEMF devices donated by the manufacturer:  BioElectronics Corp 
(Frederick, Maryland). 
 
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
Not applicable 
 

 
 
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25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
Not applicable 
 
26. IMPACT ON STAFF 
There will be no appreciable impact on nursing staff as the study intervention will take fewer than 5 
minutes while the patient is in the recovery room and will not add to recovery room stay duration; and 
will not require any attention from the recovery room nursing staff. 
 
27. CONFLICT OF INTEREST 
None 
 
28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
Not applicable 
 
29. OTHER APPROVALS/REGULATED MATERIALS 
Not applicable 
 
30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY 
ASSESSMENT 
Not applicable:  surrogate consent will not be accepted.