Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

NCT06984224 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00086182
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain, Low

Outcome Measures

Primary Outcomes (10)

• Modified Oswestry Disability Index

  MODIFIED 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.

  Pre-intervention

• Modified Oswestry Disability Index

  MODIFIED 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.

  6 weeks

• Visual Analog Pain Scale

  The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable".

  Pre-intervention

• Visual Analog Pain Scale

  The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable".

  6 weeks

• Schober Test

  Schober Test for Spinal Mobility

  Pre-intervention

• Schober Test

  Schober Test for Spinal Mobility

  6 weeks

• Quality of Life Index

  Quality 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.

  Pre-intervention

• Quality of Life Index

  Quality 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.

  6 weeks

• Heart Math HRV

  The 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".

  Pre-intervention

• Heart Math HRV

  The 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".

  6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Physical Therapy with adjunctive Neubie Pulsed Direct Current Device at 500 pps

Device: Neubie Direct Current Stimulation Device

Control

NO INTERVENTION

Standard of Care Physical Therapy

Interventions

Neubie Direct Current Stimulation Device DEVICE

Pulsed Direct Current Electrical Stimulation Device

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Normal lower limb strength
• Able to attend twice weekly physical therapy visis for up to 6 weeks
• years of age, or older

You may not qualify if:

• Currently pregnant
• Cardiac pacemaker
• Active or recently treated cancer
• Active or recent blood clots
• Epilepsy
• Open wounds
• History of lumbar spine fusion surgery
• Radicular symptoms suggesting radiculopathy or spinal stenosis.

Sponsors & Collaborators

• NeuFit - Neurological Fitness and Education: lead
• EA Therapeutic Health: collaborator
• Mayo Clinic: collaborator

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramona von Leden, PhD

  NeuFit - Neurological Fitness and Education

  STUDY DIRECTOR

Central Study Contacts

Ramona von Leden

CONTACT

5303832292; ramona.vonleden@neu.fit

Melanie Brennan

CONTACT

melanie@chooseea.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 22, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share