Clinical trial NCT05442021: Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy
Official title: Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy
Keywords: electrical stimulation
neubie
neuromuscular electrical stimulation
Lead sponsor: NeuFit - Neurological Fitness and Education
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Distal Latency
timeFrame: Pre-intervention
measure: Distal Latency
timeFrame: 6 weeks
measure: Tibial Motor Nerve Conduction Velocity
timeFrame: Pre-intervention
measure: Tibial Motor Nerve Conduction Velocity
timeFrame: 6 weeks
measure: Fibular Motor Nerve Conduction Velocity
timeFrame: 6 weeks
measure: Fibular Motor Nerve Conduction Velocity
timeFrame: Pre-intervention
measure: Ulnar Motor Nerve Conduction Velocity
timeFrame: Pre-intervention
measure: Ulnar Motor Nerve Conduction Velocity
timeFrame: 6 weeks
measure: Sural Sensory Nerve Conduction Velocity
timeFrame: Pre-intervention
measure: Sural Sensory Nerve Conduction Velocity
timeFrame: 6 weeks
measure: Superficial Fibular Sensory Nerve Conduction Velocity
timeFrame: 6 weeks
measure: Superficial Fibular Sensory Nerve Conduction Velocity
timeFrame: Pre-intervention
measure: Ulnar Sensory Nerve Conduction Velocity
timeFrame: Pre-intervention
measure: Ulnar Sensory Nerve Conduction Velocity
timeFrame: 6 weeks
measure: Tibial F-Wave
timeFrame: Pre-intervention
measure: Tibial F-Wave
timeFrame: 6 weeks
measure: H-Reflex
timeFrame: 6 weeks
measure: H-Reflex
timeFrame: Pre-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: APEX Physical Therapy
state: Florida
city: Clearwater
country: United States
facility: Catalyst Physical Therapy
state: Florida
city: Fort Myers
country: United States
facility: APEX Physical Therapy
state: Florida
city: Springfield
country: United States
facility: Diagnostic Solutions
state: Kentucky
city: Astoria
country: United States
facility: Hands-On Physical Therapy
state: New York
city: Queens Village
country: United States
facility: Hands-On Physical Therapy of Queens Village
state: New York
city: Ronkonkoma
country: United States
facility: Panetta Physical Therapy & Diagnostics
state: New York
city: Edmond
country: United States
facility: Courcier Physical Therapy
state: Oklahoma
city: El Paso
country: United States
facility: Spine & Rehab Specialists
state: Texas
city: Oak Hill
country: United States
facility: Active Fitness Physical Therapy
state: West Virginia
city: Victor
country: United States
facility: Active Fitness Physical Therapy
state: West Virginia
Study officials:
affiliation: NeuFit - Neurological Fitness and Education
name: Ramona von Leden, PhD
role: STUDY_DIRECTOR
References:
citation: Snyder MJ, Gibbs LM, Lindsay TJ. Treating Painful Diabetic Peripheral Neuropathy: An Update. Am Fam Physician. 2016 Aug 1;94(3):227-34.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.).