Back Pain, LowNCT06984224
Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain
A study testing Neubie Direct Current Stimulation Device in people with Back Pain, Low, run by NeuFit - Neurological Fitness and Education.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Back Pain, Low
- What is being tested?
- Neubie Direct Current Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 years of age, or older
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Melanie Brennan contact
About this study
Official title: Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain
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?
Read more
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.
Read the 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
- Being tested
- Neubie Direct Current Stimulation Device
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neubie Direct Current Stimulation DeviceDevice
Pulsed Direct Current Electrical Stimulation Device
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Physical Therapy with adjunctive Neubie Pulsed Direct Current Device at 500 pps Receives: Device: Neubie Direct Current Stimulation Device |
| Control | No intervention | Standard of Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 6 weeks
Schober Test
Schober Test for Spinal Mobility
Measured: Pre-intervention
Schober Test
Schober Test for Spinal Mobility
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuFit - Neurological Fitness and Education
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EA Therapeutic Health, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Ramona von Leden, PhD, Study director, NeuFit - Neurological Fitness and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984224
- Sponsor's protocol ID
- Pro00086182
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain
- ClinicalTrials.gov ID
- NCT06984224
- Acronym / sponsor ID
- Pro00086182
- Conditions
- Back Pain, Low
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NeuFit - Neurological Fitness and EducationIndustry (pharma, biotech, devices)
- Collaborators
- EA Therapeutic Health, Mayo Clinic
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Neubie Direct Current Stimulation DevicePhysical Therapy with adjunctive Neubie Pulsed Direct Current Device at 500 pps |
| Control | No intervention | –Standard of Care Physical Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 18 years of age, or older
Key exclusion criteria (8 listed)
- Currently pregnant
- Cardiac pacemaker
- Active or recently treated cancer
- Active or recent blood clots
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neubie Direct Current Stimulation DevicePulsed Direct Current Electrical Stimulation Device | Device | Experimental |
Primary outcome
Modified Oswestry Disability Index
Time frame: Pre-intervention
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.
Modified Oswestry Disability Index
Time frame: 6 weeks
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.
Visual Analog Pain Scale
Time frame: Pre-intervention
The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable".
Visual Analog Pain Scale
Time frame: 6 weeks
The Visual Analog Scale (VAS) for measuring pain ranges from 0-10, with 0 representing "no pain" and 10 representing "worst pain imaginable".
Schober Test
Time frame: Pre-intervention
Schober Test for Spinal Mobility
Schober Test
Time frame: 6 weeks
Schober Test for Spinal Mobility
Quality of Life Index
Time frame: Pre-intervention
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.
Quality of Life Index
Time frame: 6 weeks
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.
Heart Math HRV
Time frame: Pre-intervention
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".
Heart Math HRV
Time frame: 6 weeks
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Brennan contact
Ramona von Leden, PhD study director
NeuFit - Neurological Fitness and Education
Questions about this trial
What is this clinical trial studying?
A study testing Neubie Direct Current Stimulation Device in people with Back Pain, Low, run by NeuFit - Neurological Fitness and Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramona von Leden (5303832292, ramona.vonleden@neu.fit), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oswestry Disability Index (time frame: Pre-intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.