Clinical trial NCT06984224: Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain
Official title: Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Back Pain, Low
Lead sponsor: NeuFit - Neurological Fitness and Education
Sponsor class: INDUSTRY
Collaborators: name: EA Therapeutic Health
name: Mayo Clinic
First posted: 2025-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: Pre-intervention
measure: Modified Oswestry Disability Index
timeFrame: 6 weeks
measure: Visual Analog Pain Scale
timeFrame: Pre-intervention
measure: Visual Analog Pain Scale
timeFrame: 6 weeks
measure: Schober Test
timeFrame: Pre-intervention
measure: Schober Test
timeFrame: 6 weeks
measure: Quality of Life Index
timeFrame: Pre-intervention
measure: Quality of Life Index
timeFrame: 6 weeks
measure: Heart Math HRV
timeFrame: Pre-intervention
measure: Heart Math HRV
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NeuFit - Neurological Fitness and Education
name: Ramona von Leden, PhD
role: STUDY_DIRECTOR
References: