Electrical Stimulation for Pinched Nerve

Recruiting at 14 trial locations

Overseen By Ramona von Leden, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NeuFit - Neurological Fitness and Education

Disqualifiers: Pregnancy, Pacemaker, Cancer, Epilepsy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Neubie Direct Current Electrical Stimulation Device treatment for pinched nerve?

Research suggests that pulsed electrical stimulation can be effective in reducing pain for conditions like diabetic neuropathy, but direct current stimulation may cause nerve damage. Therefore, while electrical stimulation can help with pain, the specific use of direct current as in the Neubie device may not be as safe or effective. ^{1 2 3 4 5}

Is direct current electrical stimulation safe for humans?

Research indicates that direct current (DC) electrical stimulation can cause nerve damage and muscle paralysis, as it may lead to myelin and axon degeneration. While some devices are designed to minimize risks, DC stimulation is generally considered biologically unsafe without specific safety measures. ^{1 6 7 8 9}

How does electrical stimulation differ from other treatments for a pinched nerve?

Electrical stimulation is unique because it uses electrical currents to relieve pain by targeting specific nerves, which can be less invasive compared to traditional surgical options. Unlike some treatments that may involve medication or surgery, this method can be applied externally and may offer pain relief without the need for drugs or invasive procedures. ^{1 3 10 11 12}

Research Team

Ramona von Leden, PhD

Principal Investigator

NeuFit - Neurological Fitness and Education

Eligibility Criteria

This trial is for individuals experiencing lumbosacral radiculopathy, commonly known as a pinched nerve in the lower back or sacrum area. Participants should be seeking physical therapy and have no contraindications to electrical stimulation.

Inclusion Criteria

My tests show nerve issues in my lower back.

I can attend weekly sessions for 6 weeks without extended travel.

Exclusion Criteria

Cardiac pacemaker

I have open wounds.

I have had blood clots recently or currently have them.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week treatment regimen with either Neubie direct current device or TENS unit, including 12 sessions of physical therapy.

6 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations including pain scale, disability index, and nerve function tests.

6 weeks

Extension

Participants have the option to continue treatment for up to an additional 12 sessions over 6 more weeks if symptoms persist.

6 weeks

Treatment Details

Interventions

• Neubie Direct Current Electrical Stimulation Device

Trial Overview The study compares two types of electrical stimulation: a new direct current device called Neubie and the traditional TENS unit. It aims to determine which is more effective at reducing pain and improving function, neurological status, and patient satisfaction in radiculopathy treatment.

Participant Groups

Group I: Transcutaneous Electrical Stimulation Experimental Treatment 1 Intervention

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.

Group II: Neubie Direct Current Electrical Stimulation Device Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NeuFit - Neurological Fitness and Education

Lead Sponsor

Trials

4

Recruited

300+

Findings from Research

In a controlled study simulating clinical procedures, pulsed current stimulation for 5 and 25 seconds caused nonspecific inflammatory changes similar to nonstimulated nerves, indicating it does not produce harmful neuropathologic effects.

In contrast, direct current stimulation led to frequent myelin degeneration and occasional axon degeneration, suggesting that pulsed current is a safer alternative while maintaining effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of neuropathologic changes following pulsed and direct current stimulation of the mouse sciatic nerve. Hughes, GB., Bottomy, MB., Dickins, JR., et al.[2019]

The Nalu™ Neurostimulation System represents a significant advancement in peripheral nerve stimulation for chronic neuropathic pain, transitioning from invasive surgeries to minimally invasive procedures.

This device has shown effectiveness in managing various chronic pain conditions, including post-herniorrhaphy pain syndrome and complex regional pain syndrome, indicating its potential as a reliable treatment option for peripheral neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation. Kalia, H., Pritzlaff, S., Li, AH., et al.[2022]

A pilot study involving patients with painful diabetic neuropathy showed that pulsed-dose electrical stimulation significantly reduced pain levels over a 4-week treatment period, as measured by a visual analog scale.

This study is the first to report on the use of a knitted silver-plated stocking electrode for delivering electrical stimulation, suggesting it may be an effective method for alleviating burning pain in diabetic neuropathy patients with intact protective sensation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes? Armstrong, DG., Lavery, LA., Fleischli, JG., et al.[2019]

In a study involving 30 patients with painful diabetic neuropathy, pulsed-dose electrical stimulation using stocking electrodes did not show greater efficacy in reducing pain or sleep disturbance compared to a control group with minimal current.

Both the active treatment and control groups experienced similar reductions in pain and sleep disturbance scores, indicating that the pulsed electrical stimulation may not be an effective treatment for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation therapy through stocking electrodes for painful diabetic neuropathy: a double blind, controlled crossover study. Oyibo, SO., Breislin, K., Boulton, AJ.[2006]

In a three-year study involving 30 patients, dorsal column electrical stimulation for chronic pain showed a general decrease in effectiveness over time.

Patients experienced increased stimulation thresholds, suggesting that the treatment may become less effective as time progresses, indicating a need for further research on this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal column stimulation for control of pain: a three-year follow-up. Nashold, BS.[2004]

A study found that repetitive direct current (DC) stimulation on peripheral motor nerves caused significant myelin and axon degeneration, indicating a risk of permanent nerve damage and muscle paralysis.

In contrast, previous research showed that pulsed current stimulation was equally effective but much safer than DC stimulation, suggesting that pulsed current may be a better option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myelin and axon degeneration following direct current peripheral nerve stimulation: a prospective controlled experimental study. Hughes, GB., Bottomy, MB., Jackson, CG., et al.[2017]

Limited output transcranial electrical stimulation (tES) devices, such as tDCS, tACS, and tPCS, have been shown to have electrical output levels significantly lower than many FDA-cleared devices, suggesting they pose minimal risk when responsibly manufactured and marketed.

The paper establishes a comprehensive framework for the regulation and manufacturing standards of low-power tES devices, promoting safety and innovation while ensuring public access to these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. Bikson, M., Paneri, B., Mourdoukoutas, A., et al.[2018]

Using a finite element model, researchers found that placing electrodes epidurally (on the surface of the spinal cord) significantly increases the intensity of electric fields compared to placing them outside the spine, which could enhance therapeutic effects for spinal cord injury.

Optimizing electrode design, such as using a single large band electrode, can produce effective electric fields with low current density, potentially minimizing the risk of tissue damage while improving the efficacy of low-intensity direct current stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord direct current stimulation: finite element analysis of the electric field and current density. Hernández-Labrado, GR., Polo, JL., López-Dolado, E., et al.[2021]

The Safe Direct Current Stimulator (SDCS) is a new device that allows for safe direct current stimulation of neural tissue, overcoming the limitations of traditional methods that only use alternating biphasic current pulses.

The updated SDCS2 design improves upon the original SDCS1 by providing continuous stimulation without interruptions and is compact enough for use in chronic animal studies, making it a promising tool for both exciting and inhibiting neurons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe direct current stimulator 2: concept and design. Fridman, GY., Della Santina, CC.[2022]

Inductive stimulation of the frog sciatic nerve and gastrocnemius muscle was not successfully achieved using standard techniques and EMF intensities, suggesting limitations in current methods for nerve stimulation.

When stimulation did occur, it was likely due to capacitive coupling rather than pure inductive effects, with maximum induced current densities estimated between 10 to 30 mA/cm2, indicating a need for further investigation into effective stimulation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induced current constraints and capacitive effects in inductive nerve stimulation. McCarthy, S., Haradem, D.[2014]

Electrical stimulation of peripheral nerves has been used for over 30 years to treat intractable pain, but its application has been inconsistent due to challenges in defining proper use and standardizing techniques.

Recent advancements, such as percutaneous wire electrode methods, offer a minimally invasive approach to peripheral nerve stimulation, particularly for complex regional pain syndrome (CRPS) and other painful mononeuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future of peripheral nerve neurostimulation. Weiner, RL.[2019]

Electrical stimulation has a long history in pain treatment, gaining scientific credibility with the Gate Control Theory introduced in 1965, which explained how nerve stimulation can help manage pain.

Today, peripheral nerve stimulation is used effectively for various painful conditions, evolving from treating major nerves to targeted subcutaneous stimulation for specific neuropathic pain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for chronic pain. Henderson, JM.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A comparative study of neuropathologic changes following pulsed and direct current stimulation of the mouse sciatic nerve. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes? [2019]

4. England pubmed.ncbi.nlm.nih.gov

Electrical stimulation therapy through stocking electrodes for painful diabetic neuropathy: a double blind, controlled crossover study. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Dorsal column stimulation for control of pain: a three-year follow-up. [2004]

6. England pubmed.ncbi.nlm.nih.gov

Myelin and axon degeneration following direct current peripheral nerve stimulation: a prospective controlled experimental study. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Spinal cord direct current stimulation: finite element analysis of the electric field and current density. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Safe direct current stimulator 2: concept and design. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Induced current constraints and capacitive effects in inductive nerve stimulation. [2014]

11. England pubmed.ncbi.nlm.nih.gov

The future of peripheral nerve neurostimulation. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for chronic pain. [2022]