Health TrialsbyHealthPanel

Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

ConditionsRadiculopathy LumbarRadiculopathy SacralRadiculopathy Multiple Sites
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuFit - Neurological Fitness and Education

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Currently pregnant

Cardiac pacemaker

Active or recent cancer

Active or recent blood clots

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neubie Direct Current Electrical Stimulation Device

    Device

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

  • Transcutaneous Electrical Stimulation

    Device

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Neubie Direct Current Electrical Stimulation DeviceExperimental treatment 1 intervention
Group B: Transcutaneous Electrical StimulationOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-intervention
2

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.

Time frame
6 weeks
3

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.

Time frame
12 weeks
4

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

Time frame
Pre-intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NeuFit - Neurological Fitness and Education

Lead sponsor

Source ClinicalTrials.gov
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