Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy
Phase: NA
Conditions: Radiculopathy Lumbar, Radiculopathy Sacral, Radiculopathy Multiple Sites
Sponsor: NeuFit - Neurological Fitness and Education

Protocol Title  
Impact of direct current neuromuscular electrical stimulation on physical therapy treatment of 
lumbosacral radiculopathy 
 
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, neurological 
status, electrophysiological changes and patient satisfaction.  
 
Investigators 
Hands On Diagnostics: Dimitrios Kostopoulos, DPT, MD, PhD, DSc, ECS  
NeuFit: Ramona von Leden, PhD  
Setting of the Research 
To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-
term symptoms and severity of lumbosacral and thoracic radiculopathy, participants will enroll 
in a 6-week treatment regimen at one of 9 Hands-On Physical Therapy associated clinic sites 
listed included in application. The first session will consist of an intake evaluation session that 
will include: Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to 
assess functional disability, Straight Leg Raise Test to address nerve root irritation or 
compression, and Electrophysiological evaluation to determine the nerve function. These tests 
will serve as baseline (and a within subject control) for the intervention.  
 
Participants will then undergo a specialized radiculopathy protocol that includes traditional PT 
therapy as well as treatment with the Neubie (or traditional electrical stimulation) both during 
PT exercises and as additional treatment after sessions.  Subjects receive an evaluation 
session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index 
questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root 
irritation or compression, and Electrophysiological evaluation to determine the nerve function.  
 
The experimental group subjects follow with 12 sessions of physical therapy over a 6-week 
period which include 30 min of various physical therapy exercises with the Neubie. 
 
The control group subjects follow with 12 sessions of physical therapy over a 6-week period 
which include: a 30-min of various physical therapy exercises with TENS application. 
 
 At the end of the 12 sessions of treatment, subjects receive a final evaluation session that 
includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to 
assess functional disability, Straight Leg Raise Test to address nerve root irritation or 
compression, Electrophysiological evaluation to determine the nerve function, and a patient 
satisfaction questionnaire to assess patient satisfaction with the treatment. Participants will 

receive 12 treatments over 6 weeks. Measurement of these variables will provide both 
quantitative and qualitative data on the severity of radiculopathy symptoms (see “Tools for data 
collection” below). 
Clinic Sites
 
 
Hands-On Physical Therapy 
32-44 31st Street 
Astoria, NY 11106 
 
Hands-On Physical Therapy of Queens Village 
220-01 Jamaica Ave 
Queens Village, NY 11428 
 
Hands on Physical Therapy 
3867 E Tremont Avenue 
Bronx, NY, 10465 
 
APEX Physical Therapy 
15751 San Carlos Boulevard 
Suite #4 
Fort Myers, FL 33908 
 
APEX Physical Therapy 
900 SW Pine Island Rd 
Suite 112 
Cape Coral, FL 33991 
 
 
        WellHealth Physical Therapy 
      1848 Deer Park Ave 
             Deer Park, NY 11729 
 
 
WellHealth Physical Therapy 
 
265 N Broadway, Hicksville, NY 11801 
 
 
Courcier Clinic 
14017 N Eastern Ave 
 Edmond, OK 73013 
 
Catalyst Physical Therapy  
1206 Court Street 
Clearwater, FL 33756 
 
NCEPT Physical Therapy 
457 North Elm Street 

Escondido, CA 92025 
 
Spine & Rehab Specialists 
6358 Edgemere Blvd 
El Paso, Texas 79925 
 
Spine & Rehab Specialists 
11855 Physicians Drive 
El Paso, Texas 79936 
 
KORT Shepherdsville 
431 Adam Shepherd Pkwy 
Suite 1 
Shepherdsville, KY 40165 
  
KORT Bardstown 
875 Pennsylvania Ave 
Suite A 
Bardstown, KY 40004 
 
Kinetix - Haile Plantation Location  
2839 SW 87th Dr. Ste 10 
Gainesville, FL 32608 
 
Kinetix - Arbor Greens - Jonesville Location 
13559 NW 1st Ln. 
Newberry, FL 32669 
 
Adams Physical Therapy Services 
111 W North St. 
Portland, IN 47371 
 
 
 
Research Purpose and Hypothesis  
Radiculopathy is one of the most common complaints evaluated by a spine surgeon. Its 
prevalence has been estimated to be 3%-5% of the population, affecting both men and 
women. Age is a primary risk factor, as it occurs secondary to the degenerative process within 
the spinal column1. Commonly referred to as a pinched nerve, radiculopathy is injury or 
damage to nerve roots in the area where they leave the spine1. Lumbrosacral and thoracic 
radiculopathy is the most common form of radiculopathy. It occurs in the mid to lower region of 
the spine and is associated with tinging, numbness, and sciatica pain in the front and lower 
limbs of the body1,2. This condition can affect anyone and can be the result disc degeneration, 
disc herniation or other trauma2. Radiculopathy occurs often with aging. As the body starts to 
age, the discs in the spine start to degenerate and begin to bulge or can begin to dry out and 
stiffen1,2. Common symptoms associated with radiculopathy are tingling, numbness, 

weakness, pain, and decreased motor function in the lower half of the front of the body and 
legs1,2. Traditionally, non-surgical treatment for radiculopathy 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 infection3,4. In severe or chronic cases, invasive surgical 
treatments are used, including spinal decompression (discectomy) or fusion and disc 
replacement, which are associated with surgical risks (infection, poor wound healing, blood 
clots), and do not guarantee resolution of symptoms5,6.  
One non-invasive therapy for radiculopathy that has shown promise is the use of electrical 
stimulation (e-stim), a non-invasive therapeutic modality where nerves are stimulated with 
electrical current via surface electrodes to stimulate muscular contraction to improve strength 
and physical performance7. This method has been widely used for the management of 
nonacute low back pain8. It is plausible this method has potential to reduce pain in patients 
with low back pain by strengthening trunk muscles, similar to exercise. E-stim has few side 
effects and contraindications, and no known drug interactions9. E-stim is performed through 
the use of a device to send gentle electrical pulses through the skin into muscles, joints, 
bones, and nerves. E-stim has also been used successfully to increase cutaneous perfusion 
and circulation10,11, and was found to be efficacious for postoperative pain, pain after 
trauma9,12,13.  
The literature on the use of e-stim for treating radiculopathy symptoms demonstrates the 
capability of the modality to alter nerve injury. Additionally, in conditions with similar symptoms, 
like neuropathy, there is growing evidence for it’s use to improve nerve function. Cutaneous 
circulation is significantly increased with the application of e-stim, but in addition, there is 
evidence of increased vascular endothelial growth factor (a primary angiogenic factor)14,15. 
This increase suggests that e-stim may increase angiogenesis, which in turn may improve 
microcirculation associated with neuropathy, leading to reduced symptoms and improved 
nerve function14,15. Further, the application of e-stim stimulates cutaneous afferent fibers, 
which may contribute to the reported analgesic effect16. 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 signals16. 
There are a limited number of clinical studies that have investigated using e-stim for 
radiculopathy symptoms. Many have used transcutaneous e-stim (TENS), which employs low 
frequency alternating currents (AC), and have seen some effectiveness for pain associated 
with neuropathy, but has limited impact on other symptoms16. There is evidence that e-stim 
has been shown to improve outcomes in foot drop secondary to lumbar radiculopathy when 
paired with exercise-based PT, with an increase in strength in lower limbs after each 
session17. However, the efficacy of AC current on radiculopathy is unclear, as one review of 
the literature found very little difference in TENS vs sham when treating cervical radiculopathy 
symptoms18. In contrast, clinical studies have found that direct current (DC) neuromuscular e-
e-stim at higher frequencies is significantly more effective than TENS at ameliorating 
symptoms like motor function and numbness19-22. Further, one review compared the 
effectiveness of TENS versus higher-frequency e-stim devices in clinical studies of neuropathy 
and found a significantly increased percentage of patients with improvements in symptoms 
when using higher frequency e-stim compared to those using TENS16. A more specific 

illustration of this was a study that investigated the use of at high frequency home plantar e-
stim for management of neuropathy related motor-function and sensory impairments16. 
Balance, gait, stride time and length, and cadence, vascular function, and plantar sensation 
were measured at baseline, and after six weeks of plantar stimulation, all showed 
improvements. 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 able to achieve more input stimulation to 
sensory afferent signaling compared to the bidirectional flow of AC, which can cause a co-
contraction that suggests both input and output stimulation to the nervous system. In contrast, 
DC allows for more specific contractile movement at higher amplitudes, making it more useful 
and efficient for training and rehabilitation23. Further, activation of denervated muscles requires 
a longer pulse length, achievable with DC but not with AC24.    
Though limited, the current evidence suggests that high frequency direct current e-stim may 
be an effective therapeutic avenue for improvement and management of radiculopathy 
symptoms, and should be investigated further. Accordingly, the purpose of the proposed study 
is to evaluate the immediate and long-term effectiveness of repeated treatments with a high-
frequency direct current electrical stimulation device for treatment of lumbosacral 
radiculopathy. The Neubie Direct Current Electrical Stimulation Device offered by Neurological 
Fitness Equipment and Education LLC (NeuFit) is a neuromuscular electrical stimulation 
device that uses direct current electrical stimulation to stimulate muscle activation, blood flow, 
and various aspects of the nervous system. Historically, 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 device uses a direct current frequency via conductive 
pads placed at the targeted areas and counters the issue of irritation with an additional 
waveform to eliminate skin irritation by dissipating heat and any charge buildup caused by the 
direct current 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. For DPN, the Neubie would be uniquely 
suited to be used for increasing range of motion, increasing local blood circulation, preventing 
atrophy, neuromuscular re-education, reducing spasms, and management or relief of chronic 
pain. 
We hypothesize that treatment with the NEUBIE device twice a week for 6 weeks will result in 
improvement Visual Analogue Scale (VAS) score, Oswestry Disability Index questionnaire 
score, Straight Leg Raise Test degrees of movement, improved outcomes in 
Electrophysiological findings of Tibial H-Reflex and presence of degree of spontaneous 
electrical activity such as fibrillation potentials and positive sharp waves, and improvement in a 
patient satisfaction questionnaire score. The results of this study could impact future recovery 
protocols not just for radiculopathy, but any condition that results in nerve damage, muscle 
weakness, and chronic pain. 
 References.  

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Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934. PMID: 31788391; 
PMCID: PMC6858271. 
2. Tarulli A, Raynor EM. Lumbosacral radiculopathy. 
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3. Sharma H, Lee SW, Cole AA. The management of weakness caused by lumbar and 
lumbosacral nerve root compression. J Bone Joint Surg Br. 2012;94(11):1442–1447. 
4. Lewis R, Williams N, Matar HE, et al. The clinical effectiveness and cost-effectiveness of 
management strategies for sciatica: systematic review and economic model. Health Technol 
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5. Aono H, Iwasaki M, Ohwada T, et al. Surgical outcome of drop foot caused by degenerative 
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6. Girardi FP, Cammisa FP, Huang RC, et al. Improvement of preoperative foot drop after 
lumbar surgery. J Spinal Disord Tech. 2002;15:490–494. 
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assisted active cycling-therapeutic effects in patients with hemiparesis from 7 days to 6 
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diabetes mellitus. The Journal of foot and ankle surgery : official publication of the American 
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11. Gilcreast, D. M., Stotts, N. A., Froelicher, E. S., Baker, L. L. & Moss, K. M. Effect of 
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(2015). 
13. Ordog, G. J. Transcutaneous electrical nerve stimulation versus oral analgesic: a 
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emergency medicine 5, 6-10, doi:10.1016/0735-6757(87)90281-6 (1987). 
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receptors. Journal of cell science 117, 397-405, doi:10.1242/jcs.00868 (2004). 
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PMC6659990. 
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Research Design and Methodology  
To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-
term symptoms and severity of lumbosacral and thoracic radiculopathy, participants will enroll 
in a 6-week treatment regimen at one of 9 Hands-On Physical Therapy locations. The first 
session will consist of an intake evaluation session that will include: Visual Analogue Scale 
(VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight 
Leg Raise Test to address nerve root irritation or compression, and Electrophysiological 
evaluation to determine the nerve function. These tests will serve as baseline (and a within 
subject control) for the intervention.  
Patients will be assigned to either the control group (TENS unit) or the experimental group 
(Neubie) through a randomization process: All subjects will be assigned a number as they are 
cleared through the screening process. We will use a randomization schedule to assign these 
numbers, created with the Graphpad randomization calculator web application 
(https://www.graphpad.com/quickcalcs/index.cfm). We will use the block randomization 
method to build two groups of equal size, with a block size of 4. This method will satisfy our 
need for two equal groups sizes, control and experimental.   
Participants will then undergo a specialized radiculopathy protocol that includes traditional PT 
therapy with the Neubie (experimental group) or TENS unit (control group) being used during 
PT exercises. Both the experimental and control group subjects will undergo 12 30-minute 
sessions of physical therapy over a 6-week period which include pre-set physical therapy 
exercises. We hypothesize that treatment with the NEUBIE device twice a week for 6 weeks 
will result in improvement Visual Analogue Scale (VAS) score, Oswestry Disability Index 
questionnaire score, Straight Leg Raise Test degrees of movement, improved outcomes in 
Electrophysiological findings of Tibial H-Reflex, and presence of degree of spontaneous 
electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated 

by L4, L5, and S1 nerve roots, and improvement in a patient satisfaction questionnaire score. 
These variables will provide both quantitative and qualitative data on the severity of 
radiculopathy symptoms (see “Tools for data collection” below). 
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 64 subjects per group (TENS unit or Neubie device) is sufficient to detect a clinically 
important difference between timepoints assuming an effect size of 0.5 between means with 
80% power and a 5% level of significance. Considering a dropout rate of 10%, the sample size 
required will be a minimum of 141. 
Data Collection Methods 
Data will be collected via observational measurements taken by staff trained specifically on 
EMG/NCS at Hands on Diagnostics clinic sites. Consent forms and data will be stored in 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 Dimitrios Kostopoulos, DPT, MD, PhD, DSc, ECS (co-PI) and 
Ramona von Leden, PhD (Director of Research 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 in 
EMG/NCS – baseline vs session #) as a within-subject factor. 
Tools for Data Collection 
Time commitment for participants: 12 hours over 6 weeks (1-hour sessions, frequency detailed 
below). 
Materials Needed:  
NEUBIE device 
Electrodes 
Carbon Fiber Pad 
AMBU Nerve Conduction Study disposable skin electrodes 
AMBU EMG needle electrodes 
Alcohol wipes 
Cadwell Summit EMG device 

Needle Disposal Receptacle 
 Intervention/Treatment Protocol 
Neurostimulation pads (either rectangular or circular carbon fiber) 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). 
Standardized pad placement: Rectangular electrodes attached to the red leads will be placed 
on the myotome of affected nerve (as determined by EMG). To address distal denervation, the 
rectangular electrodes attached to the black leads will be placed on the Tibialis Anterior 
muscle for cases of L4 radiculopathy, Extensor Digitorum Brevis muscle (EDB) on the dorsum 
of the foot for cases of L5 radiculopathy and the Soleus muscle for cases of S1 radiculopathy, 
as indicated by EMG findings.  When multiple levels involved, then the most distal muscle will 
be selected.   
Standardized training 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, nerve conduction, and stimulation of blood flow. 
Training intensity: Participants will be asked to undergo e-stim with the Neubie at their 
“treatment threshold”. Treatment threshold will be described as “uncomfortable,” but not 
“painful” (a 5-7 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 hips, legs, feet and ankles.  
Duration of sessions: Roughly 45-60 minutes per session – 30 minutes of stimulation (either 
Neubie OR TENS application) + physical therapy exercises + time for clinical 
measurements/outcome measures. 
At the end of the 12 sessions of treatment, subjects receive a final evaluation session that 
includes a Visual Analogue Scale (VAS) score, Oswestry Disability Index questionnaire score, 
Straight Leg Raise Test degrees of movement, Electrophysiological findings of Tibial H-Reflex, 
and presence of degree of spontaneous electrical activity such as fibrillation potentials and 
positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots, and a patient 
satisfaction questionnaire score. 
Outcome Measures 
Pre and post treatment paradigm (at baseline and at 6 weeks), the following variables will be 
evaluated: Visual Analogue Scale (VAS) score, Oswestry Disability Index questionnaire score, 
Straight Leg Raise Test degrees of movement, Electrophysiological findings of Tibial H-Reflex, 
and presence of degree of spontaneous electrical activity such as fibrillation potentials and 
positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots, and a patient 
satisfaction questionnaire score. 

 
Procedures and Risks 
Risks associated with participation in this study are minimal and no greater than those 
experienced during a routine physical therapy intervention. Both AC and DC stimulation has 
been employed in physical therapy practice for over 15 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 5 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 
stimulated. 
Potential Benefits  
Participants will receive electrical stimulation treatments specifically in the lower back and leg 
regions. This 12-session course of treatments may decrease symptoms associated with 
radiculopathy, including nerve damage related weakness, numbness, and pain. Such 
improvements in pain could significantly benefit participants quality of life and physical 
mobility.  
 
Benefit to Society The use of a non-invasive medical device like the Neubie for treatment of 
peripheral neuropathy 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 keep radiculopathy related symptoms from worsening or reoccurring. It could also 
help in understanding the use of electrical stimulation in rehabilitation from neurological 
disease, nerve damage, and neuropathic pain. 
 
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 Hands On Diagnostics. 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 there are any safety concerns related to side 
effects of the e-stim. If withdrawn early due to safety concerns, clinical evaluation by a 
physician may be necessary to evaluate for additional health issues. 

Population and Sample 
Inclusion criteria: 
1.     Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straight 
leg raise test. 
2.     Must be able to attend weekly sessions for the 6-week period of the study (no extended 
travel) 
3.     Must be at least 18 years old. 
Exclusion criteria: 
1.  Currently pregnant 
2.  Cardiac pacemaker 
3.  Active or recent cancer  
4.  Active or recent blood clots  
5.  History of epilepsy 
6.  Open wounds 
7. Spinal fusion surgery 
Participant Recruitment 
Participants will be recruited from existing clinic patient population who seek treatment for 
radiculopathy. Any patient meeting the criteria who contacts any of the study sites will be told 
about the study and will be provided with a copy of the informed consent to review. Clinic 
Managers will handle enrollment at their respective sites. 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 evaluation visit. 
No incentive will be offered or provided for the study beyond treatment outcomes.  
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 minimize the risks of privacy.   
 
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 three years or longer.