## Protocol Section
### Identification Module
**NCT ID:** NCT06421558

**Brief Title:** Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

**Official Title:** Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy

#### Organization Study ID Info
**ID:** Pro00077736
#### Organization
**Class:** INDUSTRY
**Full Name:** NeuFit - Neurological Fitness and Education
### Status Module
#### Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** NeuFit - Neurological Fitness and Education

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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).

### Conditions Module

**Conditions:**

- Radiculopathy Lumbar

- Radiculopathy Sacral

- Radiculopathy Multiple Sites

**Keywords:**

- electrical stimulation

- direct current

- e-stim

- neubie

- emg

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Study will be divided into two randomly assigned groups - control and experimental. Control group will receive traditional e-stim treatment with TENS plus physical therapy. Experimental group will receive direct current e-stim treatment with the Neubie device plus physical therapy.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Outcomes will be assessed by clinicians at Hands on Diagnostics locations. Assessors will be blinded to which intervention participant has received.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Neubie Direct Current Electrical Stimulation Device

**Label:** Neubie Direct Current Electrical Stimulation Device

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: Transcutaneous Electrical Stimulation

**Label:** Transcutaneous Electrical Stimulation

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Neubie Direct Current Electrical Stimulation Device

**Description:** Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.

**Name:** Neubie Direct Current Electrical Stimulation Device

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Transcutaneous Electrical Stimulation

**Description:** Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.

**Name:** Transcutaneous Electrical Stimulation

**Other Names:**

- TENS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.

**Measure:** H-Reflex

**Time Frame:** Pre-intervention

**Description:** Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.

**Measure:** H-Reflex

**Time Frame:** 6 weeks

**Description:** EMG detection of 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

**Measure:** EMG detection of spontaneous electrical activity

**Time Frame:** Pre-intervention

**Description:** EMG detection of 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

**Measure:** EMG detection of spontaneous electrical activity

**Time Frame:** 6 weeks

**Description:** Straight Leg Raise Test degrees of movement

**Measure:** Straight Leg Raise Test

**Time Frame:** Pre-intervention

**Description:** Straight Leg Raise Test degrees of movement

**Measure:** Straight Leg Raise Test

**Time Frame:** 6 weeks

**Description:** Oswestry Disability Index Questionnaire Score

**Measure:** Oswestry Disability Index

**Time Frame:** Pre-intervention

**Description:** Oswestry Disability Index Questionnaire Score

**Measure:** Oswestry Disability Index

**Time Frame:** 6 weeks

**Description:** Visual Analog Score for pain

**Measure:** Visual Analog Score

**Time Frame:** Pre-intervention

**Description:** Visual Analog Score for pain

**Measure:** Visual Analog Score

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straight leg raise test.
* Must be able to attend weekly sessions for the 6-week period of the study (no extended travel)
* Must be at least 18 years old.

Exclusion Criteria:

* Currently pregnant
* Cardiac pacemaker
* Active or recent cancer
* Active or recent blood clots
* History of epilepsy
* Open wounds
* Spinal fusion surgery

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dimi@handsonpt.org

**Name:** Dimitrios Kostopoulos, MD, PhD, DPT

**Phone:** 9175382242

**Role:** CONTACT

**Contact 2:**

**Email:** ramona.vonleden@neu.fit

**Name:** Ramona von Leden, PhD

**Phone:** 5303832292

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Escondido

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** NCEPT Physical Therapy

**State:** California

**Status:** RECRUITING

**Zip:** 92025

**Location 2:**

**City:** Cape Coral

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** APEX Physical Therapy

**State:** Florida

**Status:** RECRUITING

**Zip:** 33991

**Location 3:**

**City:** Clearwater

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** Catalyst Physical Therapy

**State:** Florida

**Status:** RECRUITING

**Zip:** 33756

**Location 4:**

**City:** Fort Myers

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** APEX Physical Therapy

**State:** Florida

**Status:** RECRUITING

**Zip:** 33908

**Location 5:**

**City:** Gainesville

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** Kinetix Haile Plantation

**State:** Florida

**Status:** RECRUITING

**Zip:** 32608

**Location 6:**

**City:** Gainesville

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** Kinetix Arbor Greens - Jonesville

**State:** Florida

**Status:** RECRUITING

**Zip:** 32669

**Location 7:**

**City:** Portland

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** Adams Physical Therapy Services

**State:** Indiana

**Status:** RECRUITING

**Zip:** 47371

**Location 8:**

**City:** Bardstown

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** KORT Bardstown

**State:** Kentucky

**Status:** RECRUITING

**Zip:** 40004

**Location 9:**

**City:** Shepherdsville

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** KORT Sheperdsville

**State:** Kentucky

**Status:** RECRUITING

**Zip:** 40165

**Location 10:**

**City:** Astoria

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopoulos, MD, PhD, DPT

- **Phone:** 917-538-2242

- **Role:** CONTACT

**Country:** United States

**Facility:** Hands On Physical Therpay

**State:** New York

**Status:** RECRUITING

**Zip:** 11106

**Location 11:**

**City:** Deer Park

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** WellHealth Physical Therapy

**State:** New York

**Status:** RECRUITING

**Zip:** 11729

**Location 12:**

**City:** Hicksville

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** WellHealth Physical Therapy

**State:** New York

**Status:** RECRUITING

**Zip:** 11801

**Location 13:**

**City:** Queens Village

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous, MD, PhD, DPT

- **Phone:** 917-538-2242

- **Role:** CONTACT

**Country:** United States

**Facility:** Hands On Physical Therapy of Queens Village

**State:** New York

**Status:** RECRUITING

**Zip:** 11428

**Location 14:**

**City:** Edmond

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimitrios Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** Courcier Clinic

**State:** Oklahoma

**Status:** RECRUITING

**Zip:** 73013

**Location 15:**

**City:** El Paso

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.com

- **Name:** Dimi Kostopolous

- **Role:** CONTACT

**Country:** United States

**Facility:** Spine & Rehab Specialists

**State:** Texas

**Status:** RECRUITING

**Zip:** 79925

**Location 16:**

**City:** El Paso

**Contacts:**

***Contact 1:***

- **Email:** dimi@handsonpt.org

- **Name:** Dimitrios Kostopoulos

- **Role:** CONTACT

**Country:** United States

**Facility:** Spine & Rehab Specialists

**State:** Texas

**Status:** RECRUITING

**Zip:** 79936

#### Overall Officials

**Official 1:**

**Affiliation:** NeuFit - Neurological Fitness and Education

**Name:** Ramona von Leden, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.

**PMID:** 31788391

**Citation:** Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.

**PMID:** 17445735

**Citation:** Sharma H, Lee SW, Cole AA. The management of weakness caused by lumbar and lumbosacral nerve root compression. J Bone Joint Surg Br. 2012 Nov;94(11):1442-7. doi: 10.1302/0301-620X.94B11.29148.

**PMID:** 23109619

**Citation:** Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.

**PMID:** 22078311

**Citation:** Aono H, Iwasaki M, Ohwada T, Okuda S, Hosono N, Fuji T, Yoshikawa H. Surgical outcome of drop foot caused by degenerative lumbar diseases. Spine (Phila Pa 1976). 2007 Apr 15;32(8):E262-6. doi: 10.1097/01.brs.0000259922.82413.72.

**PMID:** 17426622

**Citation:** Girardi FP, Cammisa FP Jr, Huang RC, Parvataneni HK, Tsairis P. Improvement of preoperative foot drop after lumbar surgery. J Spinal Disord Tech. 2002 Dec;15(6):490-4. doi: 10.1097/00024720-200212000-00010.

**PMID:** 12468976

**Citation:** Bauer P, Krewer C, Golaszewski S, Koenig E, Muller 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. 2015 Feb;96(2):188-96. doi: 10.1016/j.apmr.2014.09.033. Epub 2014 Oct 18.

**PMID:** 25449195

**Citation:** Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523.

**PMID:** 14622808

**Citation:** Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

**PMID:** 14622708

**Citation:** Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3.

**PMID:** 9798171

**Citation:** Gilcreast DM, Stotts NA, Froelicher ES, Baker LL, Moss KM. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998 Sep-Oct;6(5):434-41. doi: 10.1046/j.1524-475x.1998.60505.x.

**PMID:** 9844163

**Citation:** da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.

**PMID:** 25665520

**Citation:** Ordog GJ. Transcutaneous electrical nerve stimulation versus oral analgesic: a randomized double-blind controlled study in acute traumatic pain. Am J Emerg Med. 1987 Jan;5(1):6-10. doi: 10.1016/0735-6757(87)90281-6.

**PMID:** 3545246

**Citation:** Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci. 2004 Jan 26;117(Pt 3):397-405. doi: 10.1242/jcs.00868. Epub 2003 Dec 16.

**PMID:** 14679307

**Citation:** Kanno S, Oda N, Abe M, Saito S, Hori K, Handa Y, Tabayashi K, Sato Y. Establishment of a simple and practical procedure applicable to therapeutic angiogenesis. Circulation. 1999 May 25;99(20):2682-7. doi: 10.1161/01.cir.99.20.2682.

**PMID:** 10338463

**Citation:** Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510.

**PMID:** 24124947

**Citation:** Wang TJ, Sung K, Wilburn M, Allbright J. Russian Stimulation/Functional Electrical Stimulation in the Treatment of Foot Drop Resulting from Lumbar Radiculopathy: A Case Series. Innov Clin Neurosci. 2019 May 1;16(5-6):46-49.

**PMID:** 31440402

**Citation:** Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.

**PMID:** 31830313

**Citation:** Reichstein L, Labrenz S, Ziegler D, Martin S. Effective treatment of symptomatic diabetic polyneuropathy by high-frequency external muscle stimulation. Diabetologia. 2005 May;48(5):824-8. doi: 10.1007/s00125-005-1728-0. Epub 2005 Apr 14.

**PMID:** 15830180

**Citation:** DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.

**PMID:** 19007541

**Citation:** Doucet BM, Griffin L. High-versus low-frequency stimulation effects on fine motor control in chronic hemiplegia: a pilot study. Top Stroke Rehabil. 2013 Jul-Aug;20(4):299-307. doi: 10.1310/tsr2004-299.

**PMID:** 23893829

**Citation:** Najafi B, Talal TK, Grewal GS, Menzies R, Armstrong DG, Lavery LA. 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. 2017 Jul;11(4):693-701. doi: 10.1177/1932296817695338. Epub 2017 Feb 1.

**PMID:** 28627217

**Citation:** Chandrasekaran S, Davis J, Bersch I, Goldberg G, Gorgey AS. Electrical stimulation and denervated muscles after spinal cord injury. Neural Regen Res. 2020 Aug;15(8):1397-1407. doi: 10.4103/1673-5374.274326.

**PMID:** 31997798

**Citation:** Zehr EP, Collins DF, Chua R. Human interlimb reflexes evoked by electrical stimulation of cutaneous nerves innervating the hand and foot. Exp Brain Res. 2001 Oct;140(4):495-504. doi: 10.1007/s002210100857.

**PMID:** 11685403

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-03-29

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 186037

- Type Abbrev: Prot_SAP

- Upload Date: 2024-04-08T16:34

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14689

- Name: Radiculopathy

- Relevance: HIGH

- As Found: Radiculopathy

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011843

- Term: Radiculopathy

### Misc Info Module

- Version Holder: 2024-05-31
