Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
Phase: NA
Conditions: Lower Back Pain
Sponsor: University of Maryland, Baltimore

 
TCMS Protocol Version: 1.0 
Protocol Date: April 25, 2016 
 
 
 
 
 
Treatment of Low Back Pain Using Transcutaneous 
Magnetic Stimulation (TCMS): A Feasibility Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
TCMS Protocol Version: 1.0 
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Table of Contents: 
1.0 
Purpose 
2.0 
Objective 
3.0 
Hypothesis 
4.0 
Product 
5.0 
Sponsor 
6.0 
Site 
7.0 
Design 
8.0 
Intervention 
9.0 
Assessments 
10.0 Additional Data Collected 
11.0 Definition of Success 
12.0 Effectiveness of Analysis 
13.0 Subject Safety  
14.0 Safety Analysis 
15.0 Safety Endpoints 
16.0 Sample Size 
17.0  Recruitment, enrollment, and eligibility confirmation 
18.0 Inclusion/Exclusion 
19.0 Visits/Phone Assessments 
20.0 Schedule of Events 
21.0 Study Duration for Subject 
22.0 Duration of Study 
23.0 Subject discontinuation or study suspension  
24.0 Protocol deviations 
25.0 Data Collection 
26.0 Data Analysis 
 
 
 
 
 
 
 
 
 
 
 

 
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1.0 
PURPOSE 
Preliminary evaluation of the safety and effectiveness of Transcutaneous Magnetic 
Stimulation (TCMS) for the relief of low back pain. 
 
2.0 
OBJECTIVE 
To perform a preliminary study of the feasibility, safety, and effectiveness of TCMS for 
the relief of low back pain. 
 
3.0  
HYPOTHESIS 
TCMS treatment will lead to a clinically meaningful reduction in lower back pain 
associated with degenerative lumbo-sacral spine disease. 
4.0 
 PRODUCT 
Zygood TransCutaneous Magnetic Stimulator (TCMS) 
 
5.0  
SPONSOR 
Robert E. Fischell 
Zygood LLC 
14600 Viburnum Drive 
Dayton, MD, 21036 
301-922-9225 
 
6.0  
SITE 
University of Maryland Rehabilitation and Orthopaedic Institute 
2200 Kernan Drive 
Gwynn Oak, MD 21207 
410-448-2500 
 
7.0 
 DESIGN 
Single-site, randomized, single -blind, placebo-controlled, trial 
 
8.0  
INTERVENTION 
Subjects will identify the location of pain on their back. A member of the study team will 
note the location on a drawing. The TCMS device will be placed at the site the patient 

 
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identified. (Low back pain is defined as pain below the costal margin posteriorly, 
extending as low as the upper buttocks.)  
 
With only a hospital gown intervening, the clinician will place the active or sham TCMS 
device on the area of pain, turn the device on, and adjust the amplitude upward from 
0.24T in increments of 10%, approximately every 6-10 seconds, until the 1.2T setting is 
achieved or the subject reports discomfort.  If the patient reports discomfort, the 
amplitude will be adjusted downward as necessary to maintain patient comfort. 
 
 
Treatment group: TCMS device set to 1.2 Tesla will deliver a dose of 10 pulses per 
minute for 9 minutes (total 90 pulses). The first minute will be dedicated to adjusting 
the amplitude until maximum is achieved and/or the subject reports a sensation. 
 
Placebo group:  the sham TCMS device will remain on the area of pain for 10 minutes.  
The sham TCMS device is engineered so as to make the same sound at the same 
intervals as the active device. The same procedures will occur as those with the active 
device. The first minute will be dedicated to adjusting the “sham”  amplitude. The 
remaining 9 minutes will be the treatment period. 
 
9.0  
ASSESSMENTS 
 
9.1  
Numeric Pain Rating Scale (NPRS):  
0 to 10 numerical pain rating scale with equally spaced numerical intervals ranging 
from 0 representing “no pain” to 10 representing the “worst imaginable pain” 
 
9.2  
Baseline severity (Pain Diary): 
Patient will document in a diary the severity of their pain on each day of the preceding 
week just prior to treatment. 
 
9.3  
Severity during treatment (immediate benefit): 
At 5- and 10-minutes 
 
9.4  
Severity after treatment is completed (treatment durability): 
 1, 2, 4, 8, 12, 24, 48 and 72 hours post-treatment.  
 
9.5  
We will also follow-up with patients at 7and 30 days post-treatment, 
 
Data collected at baseline, 7 day and 30 day follow-up:  
Global Pain Scale (GPS) 
Medication usage –Case Report Form 

 
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Non-drug treatment -Case Report Form 
Functional Status (ADLs, Mobility, Employment)- Case Report Form 
 
 
Patient satisfaction with treatment- Case Report Form 
Presence of unwanted treatment effects, including paresthesia, irritation or     
discomfort, referred pain, and motor effects. – Case Report Form 
 
10.0  ADDITIONAL DATA COLLECTED 
Demographic information (age, sex, ethnicity, employment status) and medical history 
and result of physical examination, including weight, height, pain diagnosis (noting any 
nerve compression), pain characteristics, pain etiology, pain duration, pain location 
(noting any leg pain), treatment history, and results of imaging study or studies. 
 
11.0  DEFINITION OF SUCCESS 
Treatment success is a 30% reduction in mean baseline pain score on the 0 to 10 
Numeric Pain Rating Scale (NPRS) that persists at least 1 hour and occurs at any time in 
the period from treatment through 48-hour follow-up.   
 
Study success is at least 3 of 10 treatment patients meeting the criteria for treatment 
success and no serious adverse events reported in any subject related to active 
treatment. 
 
12.0  EFFECTIVENESS OF ANALYSIS 
Quantitative, but not statistically powered, trend-analysis of effectiveness of active 
treatment vs. sham. 
 
Comparison of mean magnitude of treatment effect (change in NPRS) between sham 
and active treatment (cumulative responder analysis) 
Medication usage 
Non-drug treatment 
Global Pain Scale (GPS) 
Patient satisfaction with treatment 
Presence of unwanted treatment effects, including paresthesia, irritation or discomfort, 
referred pain, and motor effects. 
 
13.0  SUBJECT SAFETY 
Board-certified anesthesiologists are immediately available. 
 

 
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The risk level to subjects is considered minimal. The device shares technology with 
an FDA-approved TMS with which no adverse events (AEs) have been associated 
(http://www.gpo.gov/fdsys/pkg/FR-2014-07-08/html/2014-15876.htm). 
 
The “dose” of magnetic stimulation is comparable to that delivered during magnetic 
resonance imaging (MRI) but is transient and localized to the area of pain. Based upon 
clinical experience, viz. with MRI, AEs are not anticipated with this application of 
magnetic stimulation. 
 
14.0  SAFETY ANALYSIS 
Qualitative tabular record of any AEs.  
 
15.0  SAFETY ENDPOINTS 
Any undesirable sign or symptom (specific narrative documentation is required for 
abnormal motor activity, pain of different modality or location, somatic sensations of 
any kind occurring during treatment) 
 
Serious adverse event (SAE) from any cause precipitating inpatient and/or invasive 
medical evaluation/treatment 
 
Human factors: detailed evaluation regarding usability, especially  
• Misinterpretation of display 
• Mistaken entry of intended prescription 
• Injury to device operator 
• Significant interference with operation of other medical monitoring devices 
external to the patient 
 
 
16.0  SAMPLE SIZE 
20 (10 control and 10 intervention) subjects who complete treatment/sham based on 
an estimate that this number will be sufficient to reveal whether this therapy is safe and 
whether further studies are warranted to investigate the level of any clinically 
meaningful pain relief. 
 
 
17.0  RECRUITMENT, ENROLLMENT, AND ELIGIBILITY CONFIRMATION 

 
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All potential subjects identified through standard clinical practice at the site will be 
listed on a Screening Log and provided with detailed study information, including a 
description of TCMS.  
 
We anticipate that 350 patients will be screened and 20 patients will be randomized to 
either placebo or intervention 
 
If the subject is willing to participate, written informed consent will be obtained.  
 
A subject is considered provisionally enrolled upon completion of the informed consent 
process.  
 
Subjects provisionally enrolled will be taught how to complete a 7-day diary recording 
low back pain and will complete this diary before randomization (Self-Report). 
 
Subjects will not be told the pain scores are needed for study inclusion.  
 
The principal investigator or a member of the study team will review the diary to 
confirm that the subject’s mean pain intensity score meets the inclusion criteria. 
Subjects who do not complete the diary or who fail to meet preliminary pain eligibility 
requirements will not be randomized, are ineligible for participation in the study and 
will not be counted in the number of enrolled patients. In such cases, the principal 
investigator or an authorized designee will log this into the data collection system. 
If a patient is unable to tolerate at least 50% of the max 1.2T they will be excluded from 
the study.  
 
* A significant change for this study is defined as a 20% increase or decrease in 
dosing of the patient’s opioid dose and/or or a change in the medication class (adding 
or removing other types of medicine used to treat pain). 
** This exclusion is restricted to opioids, benzodiazepines and psychotropics. 
 
 
18.0  INCLUSION /EXCLUSION CRITERIA 
 
18.1 INCLUSIONS 
1. Age ≥ 18 years of age 
2. Prescription pharmacologic treatment is insufficient for treatment of pain 
3. Pain duration of ≥ 6 months 
4. Pain limits physical activity  

 
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5. Pain occurs daily 
6. Chronic low back pain, with or without leg pain, associated with MRI or other 
imaging study consistent with lumbo-sacral spine disease with or without nerve 
compression 
7. Failed back surgery patients without metal implant 
8. Pain intensity ≥ 5 at the time of enrollment and a self-reported pain score of ≥ 4 
over the 7 preceding days. 
 
18.2  EXCLUSIONS 
1. Life expectancy ≤ 6 months  
2. Oral opiate doses or active ingredient has changed significantly in past 12 
months* 
3. Received intraspinal medication (e.g., epidural, intrathecal) in the lumbar region 
of the back within the past 3months 
4. Use of intravenous pain medication in the past 3months** 
5. Active use of transcutaneous electrical nerve stimulator (TENS) (within 30 days) 
6. History of seizures 
7. History of implanted medical device, cardiac pacemaker, implantable cardiac 
defibrillator, or other implant above the knee (Cochlear etc) 
8. History of cardiac dysrhythmias 
9. Member of a vulnerable population 
10. Current or potential legal action of disability claim related to back pain 
11. Body Mass Index (BMI) of > 40 
12. Another pain condition that might confound results (e.g. back pain above the 
waistline) 
13. Pregnant women 
14. Inability to undergo study assessments or complete questionnaires independently 
15. Metal objects in the body  above knee(i.e. Aneurysm clip, bullet fragment)  
16. Active psychological co-morbidities (i.e. uncontrolled schizophrenia) 
 
19.0  VISITS/PHONE ASSESSMENTS 
Screening process ~ 60 minutes 
Eligibility confirmation (baseline), informed consent, randomization and treatment (if 
enrolled) visit ~ 90 minutes  
48-hour reminder follow-up telephone call ~30 minutes 
Final 7& 30 day assessment telephone call ~ 30 minutes  
The date of treatment will be used to calculate the time for follow-up visits. 
 
20.0 Group Allocation 

 
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Block randomization to treatment group 1 (n = 10) or 2 (n = 10). We will use the RAND 
function in Excel to assign a random number from 1-20 to each of our participants. 
Participants who are randomly assigned odd numbers will be assigned to the 
intervention group. Participants who are randomly assigned even numbers will be 
assigned to the control group. 
 
20.0  SCHEDULE OF EVENTS (SEE TABLE BELOW) 
Informed consent 
7-day pain diary to confirm eligibility (Self-report) 
Enrolled or deemed ineligible 
Randomization 
Randomized treatment  
1-, 2-, 4-, 6-, 8, 12, 24, and 48-hour follow-up 
24-hour follow-up (±8 hours) 
48-hour follow-up (± 8 hours)  
72-hour follow-up (± 8 hours)  
 
Final assessment 7 & 30 day follow-up telephone call (+ 3 days) 
 
21.0  STUDY DURATION FOR SUBJECT 
Duration of the study for a subject, including follow-up, will be approximately 30 days 
 
22.0  DURATION OF STUDY 
Recruitment, treatment, follow-up and data analysis will require approximately 120 
days. 
 
23.0  SUBJECT DISCONTINUATION OR STUDY SUSPENSION  
Eligible, randomized subjects will be replaced if lost 
 
Study enrollment will be suspended pending principal investigator’s decision in 
response to any SAE 
 
Individual participation will be suspended pending physician disposition in the 
presence of any SAE  
 
We will request that withdrawn subjects continue to fill out the study questionnaires 
and allow us to collect data. 
 

 
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24.0 
 PROTOCOL DEVIATIONS 
Protocol deviations will be recorded. 
 
25.0  DATA COLLECTION/CASE REPORT FORMS 
Researchers not involved in patient clinical care will collect data. During all study phases, 
all data will be collected on paper CRFs and later entered into the eCRFs for storage in the 
secured password-protected database. This study will utilize REDCap for data collection, 
transmission and storage. REDCap (Research Electronic Data Capture) is a secure, web-based 
application for building and managing online databases. All study data will be entered via a 
password protected, study unique REDCap database website. REDCap servers are housed in a 
data center at Vanderbilt University and all web-based information transmission is encrypted. 
REDCap was developed specifically around HIPAA-Security guidelines. REDCap has been 
disseminated for use at many institutions and currently supports > 140 academic/non-profit 
consortium partners and 11,000 research end-users (www.project-redcap.org). 
 
 
26.0  DATA ANALYSIS 
Descriptive statistics, trend analysis of endpoint means for effectiveness. Tabular 
collection of adverse events with narrative

 
 
 
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STUDY SCHEDULE AND DESCRIPTION OF DATA COLLECTION  
 Time of data collection 
Data collected 
Log entry 
 Demographics 
History 
Informed 
consent 
NPRS first rating 
or since last rating 
given  
AE  
Additional 
endpoints 
*Eligibility screened and 
offered participation  
 X 
X 
X 
X 
  
  
  
*Pain each day in 7-day 
period  
  
  
  
 
X 
X 
  
Day 1 (baseline = start of 
treatment) 
  
  
  
 
 X 
 X 
 X 
During treatment: 
5 minutes 
 
 
 
 
X 
X 
 
10 minutes 
 
 
 
 
X 
X 
 
After treatment: 
1 hour  
 
 
 
 
X 
 X 
 
2 hours 
 
 
 
 
X 
X 
 
3 hours 
 
 
 
 
X 
 X 
 
4 hours 
 
 
 
 
X 
 X 
 
8 hours 
 
 
 
 
X 
 X 
 
12 hours 
 
 
 
 
X 
 X 
 
24 hours 
 
 
 
 
X 
 X 
 
48 hours 
 
 
 
 
X 
 X 
 
72 hours 
 
 
 
 
X 
X 
 
*Final assessment 7 &  30 
days (+3) 
 
X (employment 
status only) 
 
 
X 
X 
X 
*Data can be collected in person, via mail, via telephone, email, or fax 

 
 
 
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LAY SUMMARY 
The study will evaluate whether an experimental medical device that emits a brief, 
intense magnetic field will relieve pain in the low back. The United States Food and 
Drug Administration (FDA) has approved a similar device for treatment of migraine, but 
this type of device has not been studied for the treatment of low back pain. No 
significant adverse reactions or side effects have been reported from the use of 
magnetic stimulation for headache treatment.  Some patients who have migraine 
headaches have excellent pain relief with the magnetic treatment even if they did not 
get pain relief with medications.  
 
We do not know whether magnetic treatment will relieve low back pain, so we will test 
this by applying a powerful electromagnet to the painful area of the low back. In some 
subjects, the magnet will be turned on, but in other patients the magnet will not be 
turned on. Neither subjects nor subjects' treating doctor will know whether the magnet 
was turned on or not, although the study team will know which subjects received 
treatment with magnetic pulses. The effect on pain will be recorded periodically for 2 
days. If the subjects' reported pain is reduced as a result of the magnetic treatment 
compared with subjects who did not have the magnet turned on, then the magnet might 
have reduced the pain. Additional studies will be needed to further investigate whether 
this therapy reduces low back pain. 
 
Keywords: low back pain, TCMS (Transcutaneous Magnetic Stimulation), TENS 
(Transcutaneous Electrical Nerve Stimulation) 
 
RATIONALE AND BACKGROUND  
Approximately one third of the population suffers from acute and chronic pain at any 
given time, and the lifetime incidence of low back pain is 80%. Pain has been called a 
silent epidemic. Treatment of pain with medication incurs significant risks and side 
effects; even over-the-counter medication causes occasional fatalities (e.g., 
acetaminophen or Tylenol can cause liver toxicity; and nonsteroidal anti-inflammatory 
drugs, such as aspirin and ibuprofen, can cause bleeding). Opioid medications have a 
significant potential for abuse, addiction, and adverse reactions, such as respiratory 
depression and death. 
 
Electrical stimulation for the relief of pain has been used since antiquity, and with the 
development of compact power sources and solid state electronics in the last century, it 
has become commonplace. Electrical stimulation has been applied to the peripheral 
(e.g., in the limbs) as well as the central (brain and spinal cord) nervous system, using 
implanted as well as external noninvasive devices.   
 
Electrical stimulation specifically for low back pain, the condition addressed in this 
protocol, is supported by high quality clinical trial evidence for spinal cord stimulation 
(SCS), using surgically implanted electrodes and pulse generators. Randomized 
controlled trials have shown that SCS is superior to optimal medical management and 
to repeated low back surgery in patients with persistent or recurrent low back and leg 

 
 
 
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pain following spinal surgery (North et al., 2005). High frequency SCS has been effective 
for low back pain in particular. SCS has been in use for nearly 50 years. Medtronic, Inc.; 
St. Jude Medical, Inc.; and Boston Scientific Corporation all have FDA-approved devices, 
which require surgical implantation and maintenance for the production of electrical 
pulses to relieve pain. 
 
Subcutaneous peripheral nerve field stimulation targets low back pain via electrodes 
implanted directly over the painful area and is less invasive than SCS even though it 
uses the same implanted pulse generators as SCS (Barolat et al., 2009).   
 
Transcutaneous electrical nerve stimulation (TENS), a noninvasive technique, has been 
used for several decades to treat low back pain. TENS passes current through intact 
skin via surface electrodes with conductive gels and adhesives. TENS is available 
without a prescription but is not free from side effects, notably skin pain caused by 
recruitment of small nerve fibers immediately beneath the surface of the skin [Barker 
85], which limits the usage amplitude of the electrical current and thus makes it 
difficult to stimulate deep structures.  
 
Compared with electrical stimulation, magnetic stimulation has a much shorter history 
[Thomson 1910].  Magnetic stimulation is an application of Faraday’s Law, whereby a 
high intensity magnetic pulse generates an electrical pulse within conductive media, 
including excitable tissue, viz., nerve and muscle. Magnetic stimulation has been used to 
stimulate peripheral nerves selectively [Oberg 73, Polson 82]. Compared with other 
forms of stimulation, transcutaneous magnetic stimulation (TCMS), which is 
administered through intact skin, can create larger electrical currents in nerves at 
greater depth with little, if any, skin pain [Barker 85]. In fact, magnetic stimulation can 
act through the skin and the skull to stimulate the brain, minimizing recruitment of 
overlying structures, such as pain fibers in the scalp. Such transcranial magnetic 
stimulation has been used extensively for the diagnosis and treatment of neurological 
disease (e.g., stroke) and treatment of psychiatric disease (e.g., depression).  Repetitive 
transcranial magnetic stimulation [Wassermann 98] has been used to treat a number of 
pain conditions. A meta-analysis of repetitive transcranial magnetic stimulation, 
demonstrates effectiveness for craniofacial pain syndromes [Leung 09].  "Single pulse" 
transcranial magnetic stimulation (at a much lower power than used in repetitive TMS) 
has been effective for migraine using a device that can deliver pulses, each of duration 
less than 1 msec, as often as every 30 seconds [Lipton 10, Diener 10]. 
 
TCMS (of the periphery), unlike transcranial magnetic stimulation, has received little 
attention as a treatment for pain; it has been the subject of a single published case 
series, with reportedly positive results in 5 patients with painful peripheral nerve 
injury or neuroma [Leung 14]. Modification of peripheral nerve activity—even if it is 
distal or collateral—in the same segment as a pain generator can afford substantial 
relief (North et al., 1996). The development of an effective, minimal risk, non-invasive 
treatment of pain without medication would represent a significant advance in the field. 
 

 
 
 
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The first commercial magnetic TCMS stimulators were produced in Sheffield in 1985. 
These devices consist of a capacitor charge/discharge system with associated control 
and safety electronics. Using the charging circuitry, the capacitor stores energy to a pre-
set level. When the device receives a trigger input signal, the stored energy, apart from 
that lost in the wiring and capacitor, is transferred to the stimulating coil and then 
returned to the instrument to reduce coil heating. 
 
The most widely used description of the output of magnetic stimulators is “magnetic 
field strength,” although this refers to the density of magnetic flux rather than total 
magnetic flux and is a poor measure of output produced by the stimulating coil over its 
total area. In a small coil, where the magnetic flux is concentrated in a small area, the 
magnetic field intensity is higher than in a larger coil, but the field falls off much more 
rapidly with distance. Hence a small coil is somewhat more powerful in the stimulation 
of superficial nerves, and a large coil is more suitable for structures at depth. The 
amplitude, waveform, and spatial characteristics of the induced current all play a role in 
magnetic nerve stimulation. 
 
A more accurate indicator of the stimulating power output is the induced charge 
density per phase defined as the integral of the induced current density during the rise 
time of the magnetic field. Unlike magnetic field strength, induced current density takes 
into account the effects of the amplitude and the duration of the induced stimulating 
current. Induced current density does not, however, consider the effects of the nodal 
time constant of the myelinated nerve fiber. Unfortunately, the actual value of the 
induced charge density per phase is difficult to calculate accurately due to the 
complexities of the structure being stimulated. Different areas, such as bone, fat, grey 
matter, and white matter, with differing conductivities all affect the induced current and 
its path. 
 
The stimulating coil is the only part of a magnetic nerve stimulator that needs to come 
close to, or into contact with, the patient. During the discharge of the magnetic pulse, 
the coil winding is subjected to high voltages and currents. Although the pulse generally 
lasts for less than 1ms, the forces acting on the coil winding are substantial and depend 
on the coil size, peak energy, and construction. Careful coil design is, therefore, a very 
important aspect in the construction of a magnetic stimulator. Compared with a small 
coil, large coils contain more copper mass and generally have a lower electrical 
resistance; as a result, less heat is dissipated in the windings of large coils, and because 
of their higher heat capacity, they remain usable for much longer periods before 
becoming warm. 
 
Since the magnetic field strength falls off with distance from the stimulating coil, the 
stimulus strength is at its highest close to the coil surface. The stimulation 
characteristics of the magnetic pulse, such as depth of penetration, strength, and 
accuracy, depend on the rise time, the peak magnetic energy transferred to the coil, and 
the spatial distribution of the field. The rise time and the peak coil energy are governed 
by the electrical characteristics of the magnetic stimulator and stimulating coil, 

 
 
 
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whereas the spatial distribution of the induced electric field depends on the coil 
geometry and the anatomy of the region of induced current flow. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Barolat G,. Neuromodulation. Techniques for Subcutaneous Peripheral Nerve Field 
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Diener HC. Single-pulse transcranial magnetic stimulation: a new way to treat migraine 
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