Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

NCT06421558 | Recruiting FDA Device

• 1 other identifier: Pro00077736
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 16

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.

Conditions

Radiculopathy Lumbar; Radiculopathy Sacral; Radiculopathy Multiple Sites

Keywords

electrical stimulation; direct current; e-stim; neubie; emg

Outcome Measures

Primary Outcomes (15)

• H-Reflex

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

  Pre-intervention

• H-Reflex

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

  6 weeks

• H-Reflex

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

  12 weeks

• EMG detection of spontaneous electrical activity

  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

  Pre-intervention

• EMG detection of spontaneous electrical activity

  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

  6 weeks

• EMG detection of spontaneous electrical activity

  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

  12 weeks

• Straight Leg Raise Test

  Straight Leg Raise Test degrees of movement

  Pre-intervention

• Straight Leg Raise Test

  Straight Leg Raise Test degrees of movement

  6 weeks

• Straight Leg Raise Test

  Straight Leg Raise Test degrees of movement

  12 weeks

• Oswestry Disability Index

  Oswestry Disability Index Questionnaire Score

  Pre-intervention

• Oswestry Disability Index

  Oswestry Disability Index Questionnaire Score

  6 weeks

• Oswestry Disability Index

  Oswestry Disability Index Questionnaire Score

  12 weeks

• Numeric Pain Rating Scale

  Numeric Pain Rating scale for pain

  Pre-intervention

• Numeric Pain Rating Scale

  Numeric Pain Rating Scale for pain

  6 weeks

• Numeric Pain Rating Scale

  Numeric Pain Rating Scale for pain

  12 weeks

Study Arms (2)

Neubie Direct Current Electrical Stimulation Device

EXPERIMENTAL

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.

Device: Neubie Direct Current Electrical Stimulation Device

Transcutaneous Electrical Stimulation

OTHER

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.

Device: Transcutaneous Electrical Stimulation

Interventions

Neubie Direct Current Electrical Stimulation Device DEVICE

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

Neubie Direct Current Electrical Stimulation Device

Transcutaneous Electrical Stimulation DEVICE

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

Also known as: TENS

Transcutaneous Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NeuFit - Neurological Fitness and Education: lead

Study Sites (16)

NCEPT Physical Therapy

Escondido, California, 92025, United States

RECRUITING

APEX Physical Therapy

Cape Coral, Florida, 33991, United States

RECRUITING

Catalyst Physical Therapy

Clearwater, Florida, 33756, United States

RECRUITING

APEX Physical Therapy

Fort Myers, Florida, 33908, United States

RECRUITING

Kinetix Haile Plantation

Gainesville, Florida, 32608, United States

RECRUITING

Kinetix Arbor Greens - Jonesville

Gainesville, Florida, 32669, United States

RECRUITING

Adams Physical Therapy Services

Portland, Indiana, 47371, United States

RECRUITING

KORT Bardstown

Bardstown, Kentucky, 40004, United States

RECRUITING

KORT Sheperdsville

Shepherdsville, Kentucky, 40165, United States

RECRUITING

Hands On Physical Therpay

Astoria, New York, 11106, United States

RECRUITING

WellHealth Physical Therapy

Deer Park, New York, 11729, United States

RECRUITING

WellHealth Physical Therapy

Hicksville, New York, 11801, United States

RECRUITING

Hands On Physical Therapy of Queens Village

Queens Village, New York, 11428, United States

RECRUITING

Courcier Clinic

Edmond, Oklahoma, 73013, United States

RECRUITING

Spine & Rehab Specialists

El Paso, Texas, 79925, United States

RECRUITING

Spine & Rehab Specialists

El Paso, Texas, 79936, United States

RECRUITING

Related Publications (24)

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  PMID: 17445735 BACKGROUND

• 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.

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• 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.

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  PMID: 25449195 BACKGROUND

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  PMID: 9798171 BACKGROUND

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  PMID: 9844163 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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  PMID: 23893829 BACKGROUND

• 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.

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• 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.

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MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ramona von Leden, PhD

  NeuFit - Neurological Fitness and Education

  STUDY DIRECTOR

Central Study Contacts

Dimitrios Kostopoulos, MD, PhD, DPT

CONTACT

9175382242; dimi@handsonpt.org

Ramona von Leden, PhD

CONTACT

5303832292; ramona.vonleden@neu.fit

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by clinicians at Hands on Diagnostics locations. Assessors will be blinded to which intervention participant has received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 20, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)