Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy

Neuropathy Clinical Trial

Official title:

Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05442021
• Other study ID #: Pro00063515
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: May 2023
• Source: NeuFit - Neurological Fitness and Education
• Contact: n/a
• 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 peripheral neuropathy. 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 their 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 neuropathy. Outcomes measured will include three methods of two-point discrimination, vibration sense, pain, and score on the modified Toronto Clinical Neuropathy scale.

Description:

To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of neuropathy, 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 EMG/NCS evaluation to determine severity of neuropathy and to rule out polyneuropathy, which will serve as baseline (and a within subject control) for the intervention.

Participants will then undergo a specialized neuropathy protocol that includes traditional PT therapy for neuropathy, as well as treatment with the Neubie (or traditional e-stim) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense.

The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session with the Neubie and 15-min of various physical therapy exercises.

The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min footbath with TENS and 15-min of various physical therapy exercises.

At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes an Electrodiagnostic Study, pain assessment, evaluation of two-point discrimination, and vibration sense.

Participants will receive 12 treatments over 6 weeks. EMG/NCS and a neuropathy pain questionnaire will be measured at both the initial evaluation and at the completion of the final session, and will provide both quantitative and qualitative data on the severity of neuropathy symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have a minimum score of 1 on the modified Toronto Clinical Neuropathy Score

• 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 in the lower limbs

• Active or recent blood clots in the lower limbs

• History of epilepsy

• No open wounds

Related Conditions & MeSH terms

• Neuropathy
• Peripheral Nervous System Diseases

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

Locations

Country	Name	City	State
United States	Hands-On Physical Therapy	Astoria	New York
United States	APEX Physical Therapy	Cape Coral	Florida
United States	Catalyst Physical Therapy	Clearwater	Florida
United States	Courcier Physical Therapy	Edmond	Oklahoma
United States	Spine & Rehab Specialists	El Paso	Texas
United States	APEX Physical Therapy	Fort Myers	Florida
United States	Active Fitness Physical Therapy	Oak Hill	West Virginia
United States	Hands-On Physical Therapy of Queens Village	Queens Village	New York
United States	Panetta Physical Therapy & Diagnostics	Ronkonkoma	New York
United States	Diagnostic Solutions	Springfield	Kentucky
United States	Active Fitness Physical Therapy	Victor	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
NeuFit - Neurological Fitness and Education

Country where clinical trial is conducted

United States, 

References & Publications (18)

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

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

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

Rogers LC, Andros G, Armstrong DG. Update from the Diabetic Foot Global Conference (DFCon) 2007. Int Wound J. 2007 Dec;4(4):295-7. doi: 10.1111/j.1742-481X.2007.00377.x. No abstract available. — 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

Snyder MJ, Gibbs LM, Lindsay TJ. Treating Painful Diabetic Peripheral Neuropathy: An Update. Am Fam Physician. 2016 Aug 1;94(3):227-34. — 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

Yang, Z. et al. Scoring systems to screen for diabetic peripheral neuropathy. (Cochrane Database Syst Rev. 2018 Jul 30;2018(7):CD010974. doi: 10.1002/14651858.CD010974.pub2. eCollection 2018 Jul.).

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

Ziegler D. Treatment of diabetic polyneuropathy: Update 2006. Ann N Y Acad Sci. 2006 Nov;1084:250-66. doi: 10.1196/annals.1372.008. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal Latency	The time in milliseconds that it takes the impulse to travel from the stimulation point at the wrist to the recording electrode.	Pre-intervention
Primary	Distal Latency	The time in milliseconds that it takes the impulse to travel from the stimulation point at the wrist to the recording electrode.	6 weeks
Primary	Tibial Motor Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial Motor Nerve.	Pre-intervention
Primary	Tibial Motor Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial Motor Nerve.	6 weeks
Primary	Fibular Motor Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Fibular Motor Nerve.	6 weeks
Primary	Fibular Motor Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Fibular Motor Nerve.	Pre-intervention
Primary	Ulnar Motor Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Motor Nerve.	Pre-intervention
Primary	Ulnar Motor Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Motor Nerve.	6 weeks
Primary	Sural Sensory Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Sural Sensory Nerve.	Pre-intervention
Primary	Sural Sensory Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Sural Sensory Nerve.	6 weeks
Primary	Superficial Fibular Sensory Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Superficial Fibular Sensory Nerve.	6 weeks
Primary	Superficial Fibular Sensory Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Superficial Fibular Sensory Nerve.	Pre-intervention
Primary	Ulnar Sensory Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Sensory Nerve.	Pre-intervention
Primary	Ulnar Sensory Nerve Conduction Velocity	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Ulnar Sensory Nerve.	6 weeks
Primary	Tibial F-Wave	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial F-Wave.	Pre-intervention
Primary	Tibial F-Wave	Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the Tibial F-Wave.	6 weeks
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	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