Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain
Phase: NA
Conditions: Back Pain, Low
Sponsor: NeuFit - Neurological Fitness and Education

Neubie for Low Back Pain Protocol 
Version Date 4/14/25 
 
Protocol Title  
Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain 
 
Abstract 
This study will compare two methods of electrical stimulation (alternating current and direct 
current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical 
stimulation have been used in clinical practice for physical therapy, however direct current 
stimulation is much less common and there is less known about its impact on physical therapy 
outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct 
current device, compared to traditional TENS unit in clinical physical therapy treatment of 
radiculopathy. Outcomes measured will include: pain intensity, functional status, and patient 
satisfaction.  
 
Investigators 
Primary Investigator: Melanie Brennan, PT, DPT; EA Health 
Co-PI (admin and correspondence): Ramona von Leden, PhD; NeuFit 
Consultants:  Andrea Boon, MD and Amy Rabatin, MD; Department of Physcial Medicine and 
Rehabilitation, Mayo Clinic, Rochester MN 
Clinic Site
 
 
EA Therapeutic Health 
2530 N Broadway Ave 
Rochester, MN, 55906 
 
 
Research Purpose and Hypothesis  
 
Chronic low back pain (CLBP) affects a significant portion of the global population, with 
estimates suggesting that approximately 10-20% of adults experience chronic pain lasting for 
more than three months1. The condition can lead to significant disability, impaired quality of 
life, and substantial healthcare costs. Traditionally, non-surgical treatment for back pain has 
focused mainly on physical therapy combined with steroid injections or non-steroidal anti-
inflammatory drugs, which are temporary solutions and are associated with multiple side 
effects including pain at the injection site, fever, and occasionally infection2–4. With this large 
patient population, there is a great need for non-invasive physical treatments that can avoid 
long-term pharmacologic dependence or injections. Technological advancements in physical 
therapy treatments can assist in meeting this need. One non-invasive physical therapy tool for 
back pain that has shown promise is the use of electrical stimulation (e-stim), a therapeutic 
modality where muscles and nerves are stimulated with electrical current via surface 
electrodes to stimulate muscular activation to improve strength and range of motion5. This 

method has been widely used for the management of nonacute low back pain6, and it is 
plausible that this method has greater potential to address other symptoms associated with low 
back pain such as muscle tension and weakness. E-stim has no long-term side effects, no 
known drug interactions, and has been shown to shorten treatment times, improve quality of 
life, and help reduce therapy costs by alleviating pain, inflammation, and muscle tension7–10. 
Transcutaenous e-stim is performed through the use of a device that sends gentle electrical 
pulses through the skin into muscles, joints, bones, and nerves.  
The literature on the use of e-stim for treating back pain symptoms demonstrates the capability 
of the modality to alter chronic pain. Cutaneous circulation is significantly increased with the 
application of e-stim11,12, but in addition, there is evidence of increased vascular endothelial 
growth factor (a primary angiogenic factor)13,14. This increase suggests that e-stim may 
increase angiogenesis, which in turn may improve microcirculation, leading to reduced 
symptoms and improved nerve function overall13,14. Further, the application of e-stim 
stimulates cutaneous afferent fibers, which may contribute to reported analgesic effects12. Pre-
clinical studies suggest that e-stim inhibits nociception at the presynaptic level in the dorsal 
horn, effectively reducing pain by limiting the transmission of pain signals15. E-stim has been 
found to be efficacious for postoperative pain and pain after trauma10,16,17.  
There are a number of clinical studies that have investigated the use of e-stim for back 
pain6,18,19; however, generally these studies do not have control groups and were lacked 
objective measurements with results based solely on subjective questionnaires and pain 
assessment scales. Other clinical studies using e-stim for neuropathy, a common comorbidity 
of back pain, have found that direct current (DC) neuromuscular e-stim at higher frequencies is 
significantly more effective than alternating current (AC) e-stim like TENS at ameliorating 
symptoms such as reduced motor function and numbness20–23.  
This difference in efficacy between high frequency e-stim and TENS may be in part due to the 
use of higher frequency DC as opposed to AC. The unidirectional flow of DC fields is more 
useful for rehabilitation work as it is achieves greater input to sensory afferent signaling 
compared to the bidirectional flow of AC, which can cause a co-contraction that suggests both 
input and output stimulation of the nervous system. In contrast, DC allows for more specific 
contractile movement at higher amplitudes, making it more useful and efficient for training and 
rehabilitation24. Further, activation of denervated muscles requires a longer pulse length, 
achievable with DC but not with AC25. Importantly, one study showed that using DC e-stim for 
low back pain penetrated deeper into the tissues and resulted in a significant decrease in pain 
and improvement in function in patients suffering from low back pain on both subjective and 
objective outcomes, and was more effective and efficient than TENS5. 
The current evidence suggests that DC e-stim may be an effective therapeutic avenue for 
improvement and management of back pain. Historically, however, DC current has been less 
useful in the clinical setting, as the continuous unidirectional flow of ions leads to a buildup of 
charge that can cause skin irritation. The Neubie DC Electrical Stimulation Device offered by 
Neurological Fitness Equipment and Education LLC (NeuFit) is a neuromuscular electrical 
stimulation device that uses DC e-stim to stimulate muscle activation, blood flow, and the 
nervous system. The Neubie device uses a DC frequency via conductive pads placed at the 
targeted areas and counters the issue of irritation with an additional waveform that eliminates 

skin irritation by dissipating heat and any charge buildup caused by the DC stimulation. The 
Neubie device is FDA cleared for the following indications: 1) Maintaining or increasing range 
of motion, 2) Increasing local blood circulation, 3) Neuromuscular re-education, 4) Preventing 
atrophy, 5) Reducing spasms, 6) Preventing venous thrombosis after surgery, 7) Management 
or relief of chronic pain, and 8) Management of post-surgical and post-traumatic acute pain. 
The only two contraindications are: 1) the presence of a cardiac pacemaker and 2) pregnancy. 
In validation of the Neubie’s unique impact, a recently published study has demonstrated that 
treatment of neuropathy with the Neubie device resulted in statistically significant 
improvements in pain, vibration sense, and two-point discrimination, as well as improving 
nerve conduction velocity, distal latency, and amplitude, as measured by electromyography 
(EMG), and as compared to treatment with TENS, which showed no significant improvements 
in any outcome measures26.  These findings further support the uniquely suitable use of the 
Neubie in treatment of low back pain, as it can improve range of motion, increase local blood 
circulation, prevent atrophy, promote neuromuscular re-education, reduce spasms, and 
decrease chronic pain. 
The aim of the current study is to assess the effects of treating low back pain using DC e-stim 
delivered by the Neubie. The study assesses the efficacy of the Neubie on reduction of pain, 
improvement in range of motion of the lumbar spine, and improvement in mobility. We 
hypothesize that combined therapy including exercises and use of DC e-stim over a 4-6 week 
course of twice weekly physcial therapy will result in greater and/or more rapid improvement in 
all outcome measures (Modified Owestry Pain Scale, Visual Analog Pain Scale, Schober test 
for mobility and Quality of Life Index). These measures provide both quantitative and 
qualitative data on the severity of back pain symptoms.The results of this study could impact 
future recovery protocols not just for back pain, but for other conditions that result in nerve 
damage, muscle weakness, and chronic pain. 
 
Research Design and Methodology  
Subjects: 
Patients over the age of 17 presenting to EA Therapeutic Health physcial therapy practice in 
Rochester MN with axial low back pain will be offered study inclusion if they meet inclusion 
and exclusion criteria.  Eligible subjects will sign informed consent, and will be enrolled in a 4 
to 6 week treatment regimen at EA Therapeutic Health.  
Subjects will be assigned to either the control group (standard of care) or the experimental 
group (Neubie) through a randomization process: All subjects will be assigned a number after 
completing screeningand informed consent. A block randomization method will be created 
using the Graphpad randomization calculator web application 
(https://www.graphpad.com/quickcalcs/index.cfm) to build two groups of equal size (control 
and experimental), with a block size of 4.  
Methods: 
To determine the efficacy of direct current electrical stimulation (the Neubie device) on back 
pain, patients presenting with mechanical, non-radicular low back pain will enroll in a 4 to 6 

week treatment regimen at EA Therapeutic Health. The first session will consist of an intake 
evaluation session that will include: Modified Owestry Pain Scale, The Schober test for 
mobility, Heart Rate Variability, and Quality of Life Index. These tests will serve as baseline 
(and a within subject control) for the intervention. 
Participants will then undergo a treatment protocol that incorporates either traditional PT 
exercises (standard of care control) or PT exercises with the Neubie utilized concurrently 
(experimental group). Subjects will undergo an evaluation session prior to starting treatment 
that includes the Modified Owestry Pain Scale, The Schober test for mobility, Heart Rate 
Variability, and Quality of Life Index.  
 
The experimental group subjects will undergo 12 sessions of physical therapy over a 4 to 6-
week period which include 45 min of various physical therapy exercises concurrently with the 
Neubie followed by a 15 minute passive Vagus nerve stimulation protocol with the Neubie. 
Control group subjects will participate in a physical therapy protocol that includes manual 
therapy (e.g. trigger point release, mobilization of the SI joint) and exercises for back 
strengthening and stretching. Experimental group subjects will participate in a physical therapy 
protocol that includes manual therapy (e.g. trigger point release, mobilization of the SI joint) 
and exercises for back strengthening and stretching in conjunction with Neubie DC e-stim. 
Both control and experimental groups will receive a customized Home Exercise Program with 
exercises to be performed at home 1 time a day. 
Sample size: A power analysis was performed to determine appropriate minimum sample size 
for recruitment. Based on a power analysis using G*Power, we will analyze our data using a 
repeated measures ANOVA for within-subject factors (baseline vs post treatment). A sample 
size of 42 subjects, 21 in each arm, is sufficient to detect a clinically meaningful difference of 
0.5 between groups assuming an effect size of 0.8 between means with 80% power and a 5% 
level of significance. Considering a dropout rate of 10%, the sample size required is 46 (23 per 
group). 
Data Collection Methods 
Data will be collected via objective/observational measurements taken by staff trained at EA 
Therapeutic Health. Consent forms and data will be stored in a HIPAA compliant EMR system 
and a locked cabinet. Data will be kept for a period of 5 years after the final report has been 
produced. Thereafter, the data will be destroyed. Detailed description of these measurements 
is included in the methodology section. Data analysis and manuscript preparation based on 
findings will be performed by Melanie Brennan, PT, DPT (co-PI) and Ramona von Leden, PhD 
(Vice President of Research and Clinical Affairs at NeuFit). 
Participant data will be analyzed to test for an intervention main effect and symptoms at 
beginning and end of treatment completion (time X intervention). Measurements at the final 
treatment session will be compared to baseline with an ANOVA (significant changes– baseline 
vs session #) as a within-subject factor. 
Tools for Data Collection 

Time commitment for participants: 12 hours over 4-6 weeks (1-hour sessions, frequency 
detailed below). 
Materials Needed:  
NEUBIE device 
Electrodes 
Carbon Fiber Pads 
Intervention/Treatment Protocol 
Duration and Number of Treatment Sessions: Participants will undergo 12 treatment sessions 
over the course of 4-6 weeks. Treatments will be roughly 60 minutes per session – 45 minutes 
of physical therapy exercises (either standard of care OR DC e-stim as outlined below  + 15 
minutes Vagus nerve stimulation via the “master reset” program). Additional time will be 
needed for the initial evaluation session and the 12th or final session for clinical 
measurements/outcome measures. Outcome measures will be collected at baseline (initial 
evaluation session) and after the 12th or final treatment session.  
Stimulation with the Neubie (Experimental Group) 
Standardized stimulation frequencies: Electrical frequencies used are standardized via 
NeuFit’s protocols. The pulses per second (PPS) determine the type of stimulation being 
provided. Frequencies on the Neubie range from 1-500 PPS. The PPS designated here (500 
PPS) causes a smoother stimulation (rather than intermittent contractions) that results in 
relaxation to support increased range of motion, strength and stimulation of blood flow. 
Electrical stimulation pad placement and intensity: Neurostimulation pads (either rectangular 
or circular) are linked to electrodes (designated red and black) for paired placement on the 
skin. Pad colors determine polarity of electrical current (Red = positive, Black = negative; 
typical direction of electron current flow is Black to Red).  
For the PT exercises component of treatment, pad placement will be on the back and hips, 
with specific location determined by the physical therapist. Participants will be asked to 
perform exercises actively while receiving stimulation with the Neubie at their “treatment 
threshold”. Treatment threshold will be described as “productively uncomfortable,” but not 
“painful” (a 7 out of 10 on a perceived intensity scale). While being stimulated, participants will 
be asked to undergo a variety of PT exercises to mobilize their back and hips. 
For the Vagus nerve stimulation portion of treatment, pad placement is standardized by the 
Neubie “Master Reset” protocol: red circular pads will be placed bilaterally at the upper 
cervical spine under the mastoid process, and the black pads will be placed bilaterally on the 
balls of the feet. Participants will be asked to lie passively for 15 minutes while receiving 
stimulation with the Neubie at a “comfortable” intensity (a 4 out of 10 on a perceived intensity 
scale). This protocol is believed to increase parasympathetic activity of the autonomic nervous 
system via external stimulation of the vagus nerve and support relaxation and recovery after 

exercise therapy. 
Standard of Care (Control Group) 
Participants designated to the standard of care group will receive 45-60 minutes of physical 
therapist supervised exercises.  
Outcome Measures 
Pre and post treatment paradigm (at baseline and after 12th or final session) - the following 
variables will be evaluated: Modified Owestry Disability Index, Visual Analog Pain Scale, The 
Schober test for mobility and Quality of Life Index.  
Procedures and Risks 
Risks associated with participation in this study are minimal and no greater than those 
experienced during a routine physical therapy intervention. DC e-stim has been employed in 
physical therapy practice for over 40 years. Risks associated with electrical stimulation include 
mild discomfort caused by the sensation of the electrical stimulation (buzzing, tingling), and 
possible delayed onset muscle soreness (DOMS) after sessions. 
This therapy is non-invasive, and stimulation intensity is governed by the participant. The 
patient will be asked to tolerate some discomfort with a perceived intensity level of 7 out of 10 
but will never be asked to tolerate intensity that causes pain. Further, they will be monitored for 
the duration of the sessions by their practitioner and will never be left alone while being treated 
with DC e-stim. 
Potential Benefits  
It is expected that both control and experimental groups will have improvement in their axial 
low back pain over the course of physical therapy.Such improvements in pain could 
significantly benefit participants’ quality of life, sleep quality and physical function, and allow 
quicker return to work.  
 
Benefit to Society The use of a non-invasive medical device like the Neubie for treatment of 
back pain could have several major benefits. Most substantially, it could validate a treatment 
that could be used in both a clinic setting, or with proper training, at home by patients, to 
mitigate back pain and keep it from worsening or reoccurring. It could also help in 
understanding the use of electrical stimulation in rehabilitation for acute and chronic pain 
conditions, and neuromuscular re-education. 
 
Data Safety Monitoring 
The study does not have a data and safety monitoring board, but the researchers have an 
internal plan for data and safety monitoring. Safety information will be collected by staff at 
Neufit and EA Therapeutic Health. All personnel involved with patient interactions will have 

completed necessary HIPAA training. 
Safety data collection will start from recruitment and will be collected at each treatment 
session. The data, specifically patient health and response to treatment, will be reviewed by 
the PIs monthly. Research will be suspended if there is any indication of injury or increased 
pain to participants. Patients will be withdrawn early from the study if there is an indication that 
they are unable to comply with the protocol or if there are any safety concerns related to side 
effects of the DC e-stim. Any early withdrawals due to safety concerns will be referred to a 
physician specializing in rehabilitation medicine for further evaluation 
Population and Sample 
Inclusion criteria: 
1. 
Must show evidence of axial mechanical low back pain at least 3/10 on visual 
analog scale, without radiation to the lower limbs. Pain has to have been present 
for at least two weeks or diagnosed as chronic.  
2. 
Normal lower limb strength 
3. 
Able to attend twice weekly physical therapy visis for up to 6 weeks 
4. 
18 years of age, or older 
Exclusion criteria: 
1. 
Currently pregnant 
2. 
Cardiac pacemaker 
3. 
Active or recently treated cancer 
4. 
Active or recent blood clots 
5. 
Epilepsy 
6. 
Open wounds 
7. 
History of lumbar spine fusion surgery 
8. 
Radicular symptoms suggesting radiculopathy or spinal stenosis.  
Participant Recruitment 
Participants will be recruited when presenting for an initial physical therapy episode of care 
to address mechanical low back pain. Physical therapy treatment sessions will be billed to 
insurance as is the standard of care for this treatment approach. Any patient meeting the 
inclusion criteria will be told about the study and, if interested, provided with a copy of the 
informed consent to review. During phone or in person consultation, patients who are 
interested in joining the study will be required to enroll and submit the signed informed consent 
form prior to their first study visit. In addition to treatment outcomes, a $50 gift card will be 
provided to participants upon completion of their treatment sessions and final assessments. 
Privacy and Confidentiality 
Initial recruitment may occur over the phone, but all additional consent processes and 
procedures will occur behind closed doors in private treatment rooms with only staff involved in 
conducting the study present to maximize confidentiality.   

 
Results of this study may be used in publications and presentations. The study data will be 
handled as confidentially as possible. Individual names and personal identification information 
will not be collected at any point. Data may be shared for use in future studies or with other 
researchers. In this case, any personal identifying information of participants will not be 
included.   
 
Participant data will be stored without any identifiers or codes for 5 years.  
 
References. 
1. Manchikanti, L., Singh, V., Falco, F. J. E., Benyamin, R. M. & Hirsch, J. A. Epidemiology of 
low back pain in adults. Neuromodulation J. Int. Neuromodulation Soc. 17 Suppl 2, 3–10 
(2014). 
2. Sharma, H., Lee, S. W. J. & Cole, A. A. The management of weakness caused by lumbar 
and lumbosacral nerve root compression. J. Bone Joint Surg. Br. 94, 1442–1447 (2012). 
3. Lewis, R. et al. The clinical effectiveness and cost-effectiveness of management 
strategies for sciatica: systematic review and economic model. Health Technol. Assess. 
Winch. Engl. 15, 1–578 (2011). 
4. Qaseem, A. et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back 
Pain: A Clinical Practice Guideline From the American College of Physicians. Ann. Intern. 
Med. 166, 514–530 (2017). 
5. Bauer, P., Krewer, C., Golaszewski, S., Koenig, E. & Müller, F. Functional electrical 
stimulation-assisted active cycling--therapeutic effects in patients with hemiparesis 
from 7 days to 6 months after stroke: a randomized controlled pilot study. Arch. Phys. 
Med. Rehabil. 96, 188–196 (2015). 

6. Glaser, J. A., Baltz, M. A., Nietert, P. J. & Bensen, C. V. Electrical muscle stimulation as an 
adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized 
trial. J. Pain 2, 295–300 (2001). 
7. Bilgin, S. et al. Effects of exercise and electrical stimulation on lumbar stabilization in 
asymptomatic subjects: a comparative study. J. Back Musculoskelet. Rehabil. 26, 261–
266 (2013). 
8. Hazime, F. A. et al. Analgesic efficacy of cerebral and peripheral electrical stimulation in 
chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. 
BMC Musculoskelet. Disord. 16, 7 (2015). 
9. Kim, S. Y. et al. The effects of transcutaneous neuromuscular electrical stimulation on 
the activation of deep lumbar stabilizing muscles of patients with lumbar degenerative 
kyphosis. J. Phys. Ther. Sci. 28, 399–406 (2016). 
10. Sluka, K. A. & Walsh, D. Transcutaneous electrical nerve stimulation: basic science 
mechanisms and clinical effectiveness. J. Pain 4, 109–121 (2003). 
11. Peters, E. J. et al. The benefit of electrical stimulation to enhance perfusion in persons 
with diabetes mellitus. J. Foot Ankle Surg. Off. Publ. Am. Coll. Foot Ankle Surg. 37, 396–
400; discussion 447-448 (1998). 
12. Gilcreast, D. M., Stotts, N. A., Froelicher, E. S., Baker, L. L. & Moss, K. M. Effect of electrical 
stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. 
Wound Repair Regen. Off. Publ. Wound Heal. Soc. Eur. Tissue Repair Soc. 6, 434–441 
(1998). 

13. Zhao, M., Bai, H., Wang, E., Forrester, J. V. & McCaig, C. D. Electrical stimulation directly 
induces pre-angiogenic responses in vascular endothelial cells by signaling through 
VEGF receptors. J. Cell Sci. 117, 397–405 (2004). 
14. Kanno, S. et al. Establishment of a simple and practical procedure applicable to 
therapeutic angiogenesis. Circulation 99, 2682–2687 (1999). 
15. Thakral, G. et al. Electrical stimulation as an adjunctive treatment of painful and 
sensory diabetic neuropathy. J. Diabetes Sci. Technol. 7, 1202–1209 (2013). 
16. Ordog, G. J. Transcutaneous electrical nerve stimulation versus oral analgesic: a 
randomized double-blind controlled study in acute traumatic pain. Am. J. Emerg. Med. 5, 
6–10 (1987). 
17. da Silva, M. P., Liebano, R. E., Rodrigues, V. A., Abla, L. E. F. & Ferreira, L. M. 
Transcutaneous electrical nerve stimulation for pain relief after liposuction: a 
randomized controlled trial. Aesthetic Plast. Surg. 39, 262–269 (2015). 
18. Rajfur, J. et al. Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A 
Comparative Clinical Pilot Study. Med. Sci. Monit. Int. Med. J. Exp. Clin. Res. 23, 85–100 
(2017). 
19. Rushton, D. N. Electrical stimulation in the treatment of pain. Disabil. Rehabil. 24, 407–
415 (2002). 
20. Reichstein, L., Labrenz, S., Ziegler, D. & Martin, S. Effective treatment of symptomatic 
diabetic polyneuropathy by high-frequency external muscle stimulation. Diabetologia 
48, 824–828 (2005). 

21. DeSantana, J. M., Walsh, D. M., Vance, C., Rakel, B. A. & Sluka, K. A. Effectiveness of 
transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. 
Curr. Rheumatol. Rep. 10, 492–499 (2008). 
22. Doucet, B. M., Lam, A. & Griffin, L. Neuromuscular electrical stimulation for skeletal 
muscle function. Yale J. Biol. Med. 85, 201–215 (2012). 
23. Najafi, B. et al. Using Plantar Electrical Stimulation to Improve Postural Balance and 
Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized 
Double Blinded Study. J. Diabetes Sci. Technol. 11, 693–701 (2017). 
24. Chandrasekaran, S., Davis, J., Bersch, I., Goldberg, G. & Gorgey, A. S. Electrical 
stimulation and denervated muscles after spinal cord injury. Neural Regen. Res. 15, 
1397–1407 (2020). 
25. Zehr, E. P., Collins, D. F. & Chua, R. Human interlimb reflexes evoked by electrical 
stimulation of cutaneous nerves innervating the hand and foot. Exp. Brain Res. 140, 
495–504 (2001). 
26. Kostopoulos, D. et al. An Open-Label Comparative Study of the Impact of Two Types of 
Electrical Stimulation (Direct Current Neuromuscular Electrical Stimulation and 
Transcutaneous Electrical Stimulation) on Physical Therapy Treatment of Diabetic 
Peripheral Neuropathy. J. Diabetes Res. 2025, 9970124 (2025).