Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

NCT ID: NCT06984224

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-03-31

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.

Conditions

Back Pain, Low

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Neubie Direct Current Stimulation Device

Intervention Type: DEVICE

Pulsed Direct Current Electrical Stimulation Device

Control

Standard of Care Physical Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neubie Direct Current Stimulation Device

Pulsed Direct Current Electrical Stimulation Device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EA Therapeutic Health

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

NeuFit - Neurological Fitness and Education

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramona von Leden, PhD

Role: STUDY_DIRECTOR

NeuFit - Neurological Fitness and Education

Central Contacts

Ramona von Leden

Role: CONTACT

ramona.vonleden@neu.fit

5303832292

Melanie Brennan

Role: CONTACT

melanie@chooseea.org

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00086182

Identifier Type: -

Identifier Source: org_study_id