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Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06984224
Enrollment
40
Registered
2025-05-22
Start date
2025-06-30
Completion date
2026-03-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Low

Brief 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.

Detailed description

To determine the efficacy of direct current (DC) electrical stimulation (the Neubie device) on back pain, patients presenting with mechanical, non-radicular low back pain will enroll in a 4 to 6 week treatment regimen at EA Therapeutic Health. The first session will consist of an intake evaluation session that will include: Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. These tests will serve as baseline (and a within subject control) for the intervention. Participants will then undergo a treatment protocol that incorporates either traditional physical therapy (PT) exercises (standard of care control) or PT exercises with the Neubie utilized concurrently (experimental group). Subjects will undergo an evaluation session prior to starting treatment that includes the Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. The experimental group subjects will undergo 12 sessions of physical therapy over a 4 to 6-week period which include 45 min of various physical therapy exercises concurrently with the Neubie followed by a 15 minute passive Vagus nerve stimulation protocol with the Neubie. Control group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the sacroiliac (SI) joint and exercises for back strengthening and stretching. Experimental group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the SI joint) and exercises for back strengthening and stretching in conjunction with Neubie DC e-stim. Both control and experimental groups will receive a customized Home Exercise Program with exercises to be performed at home 1 time a day.

Interventions

DEVICENeubie Direct Current Stimulation Device

Pulsed Direct Current Electrical Stimulation Device

Sponsors

EA Therapeutic Health
CollaboratorUNKNOWN
Mayo Clinic
CollaboratorOTHER
NeuFit - Neurological Fitness and Education
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Must show evidence of axial mechanical low back pain at least 3/10 on visual analog scale, without radiation to the lower limbs. Pain has to have been present for at least two weeks or diagnosed as chronic . 2. Normal lower limb strength 3. Able to attend twice weekly physical therapy visis for up to 6 weeks 4. 18 years of age, or older

Exclusion criteria

1. Currently pregnant 2. Cardiac pacemaker 3. Active or recently treated cancer 4. Active or recent blood clots 5. Epilepsy 6. Open wounds 7. History of lumbar spine fusion surgery 8. Radicular symptoms suggesting radiculopathy or spinal stenosis.

Design outcomes

Primary

MeasureTime frameDescription
Modified Oswestry Disability IndexPre-interventionMODIFIED OSWESTRY DISABILITY SCALE - Each question is scored from 0-5 (minimum to maximum). The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability.
Visual Analog Pain ScalePre-interventionThe Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing no pain and 10 representing worst pain imaginable.
Schober TestPre-interventionSchober Test for Spinal Mobility
Quality of Life IndexPre-interventionQuality of Life Index Score has a range from 0 to 100. Lower values represent poorer quality of life, while higher values indicate better quality of life.
Heart Math HRVPre-interventionThe Heart Math HRV system takes a reading of the participant's HRV. This is provided in a numerical value which will be used as the HRV score.

Contacts

Primary ContactRamona von Leden
ramona.vonleden@neu.fit5303832292
Backup ContactMelanie Brennan
melanie@chooseea.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026