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Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

NCT06984224 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-22

No results posted yet for this study

Summary

The goal of this interventional clinical trail is to determine the efficacy of the use of the Neubie pulsed direct current electrical stimulation device for the treatment of participants experiencing mechanical low back pain. The main question it aims to answer is:

Does treatment with the Neubie improve symptoms and time to resolution of back pain compared to standard of care?

Researchers will compare a 12 session treatment physical therapy regimen using the Neubie to standard of care to see if there is a difference in symptom severity and time to resolution.

Participants will:

* Visit the clinic 2 times a week to undergo active physical therapy treatments with or without electrical stimulation from the Neubie.
* Undergo testing and fill out surveys on evaluation and final session on quality of life, disability, pain, and spinal mobility.

Conditions

  • Back Pain, Low

Interventions

DEVICE

Neubie Direct Current Stimulation Device

Pulsed Direct Current Electrical Stimulation Device

Sponsors & Collaborators

  • EA Therapeutic Health

    collaborator UNKNOWN

  • Mayo Clinic

    collaborator OTHER

  • 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
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Device
Yes

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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 NCT06984224 on ClinicalTrials.gov