MedTrace Logo

Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

NCT06421558 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-29

No results posted yet for this study

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.

Conditions

  • Radiculopathy Lumbar
  • Radiculopathy Sacral
  • Radiculopathy Multiple Sites

Interventions

DEVICE

Neubie Direct Current Electrical Stimulation Device

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

DEVICE

Transcutaneous Electrical Stimulation

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

Sponsors & Collaborators

  • NeuFit - Neurological Fitness and Education

    lead INDUSTRY

Principal Investigators

  • Ramona von Leden, PhD · NeuFit - Neurological Fitness and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-05-01
Completion
2025-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421558 on ClinicalTrials.gov