Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

Radiculopathy Lumbar Clinical Trial

Official title:

Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421558
• Other study ID #: Pro00077736
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: NeuFit - Neurological Fitness and Education
• Contact: Dimitrios Kostopoulos, MD, PhD, DPT
• Phone: 9175382242
• Email: dimi[@]handsonpt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiculopathy
• Radiculopathy Lumbar

Intervention

Device:
• Neubie Direct Current Electrical Stimulation Device
Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.
• Transcutaneous Electrical Stimulation
Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.

Locations

Country	Name	City	State
United States	Hands On Physical Therpay	Astoria	New York
United States	KORT Bardstown	Bardstown	Kentucky
United States	APEX Physical Therapy	Cape Coral	Florida
United States	Catalyst Physical Therapy	Clearwater	Florida
United States	WellHealth Physical Therapy	Deer Park	New York
United States	Courcier Clinic	Edmond	Oklahoma
United States	Spine & Rehab Specialists	El Paso	Texas
United States	Spine & Rehab Specialists	El Paso	Texas
United States	NCEPT Physical Therapy	Escondido	California
United States	APEX Physical Therapy	Fort Myers	Florida
United States	Kinetix Arbor Greens - Jonesville	Gainesville	Florida
United States	Kinetix Haile Plantation	Gainesville	Florida
United States	WellHealth Physical Therapy	Hicksville	New York
United States	Adams Physical Therapy Services	Portland	Indiana
United States	Hands On Physical Therapy of Queens Village	Queens Village	New York
United States	KORT Sheperdsville	Shepherdsville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
NeuFit - Neurological Fitness and Education

Country where clinical trial is conducted

United States, 

References & Publications (24)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Straight Leg Raise Test	Straight Leg Raise Test degrees of movement	Pre-intervention
Primary	Straight Leg Raise Test	Straight Leg Raise Test degrees of movement	6 weeks
Primary	Oswestry Disability Index	Oswestry Disability Index Questionnaire Score	Pre-intervention
Primary	Oswestry Disability Index	Oswestry Disability Index Questionnaire Score	6 weeks
Primary	Visual Analog Score	Visual Analog Score for pain	Pre-intervention
Primary	Visual Analog Score	Visual Analog Score for pain	6 weeks