Trial to Test the Efficacy of Using Magnetic Fields to Stimulate the Back to Treat Chronic Lower Back Pain.

June 11, 2026 updated by: Joe X. Zhang

A Single-Blind Randomized Clinical Trial to Evaluate the Efficacy of High Vector Electrokinetics (HiVE), A Form of Peripheral Magnetic Stimulation, In Treatment of Chronic Back Pain

The goal of this study is to see if a new way to treat back pain without the use of medications is effective. We plan use Transcranial Magnetic Stimulation (TMS), a wand-like device, to excite the nerves of people with lower back pain to see if we can decrease pain and improve quality of life.

This study will have two groups and randomly assign participants to a group. One group will have their back nerves stimulated with the TMS device and the other group will not.

Participants will also need to do back exercises at home once a day, and complete questionnaires at each visit before and after each treatment. The total time commitment will be 5 to10 visits with one visit occurring each weekday and each visit lasting up to 30 minutes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this research study is to learn about magnetic nerve stimulation and if it can help treat back pain. We believe that magnetic nerve stimulation may improve pain symptoms. Nerve stimulation using electricity and needles is a relatively common medical procedure. This study will use magnetic fields to stimulate nerves to see if it has the same or better effect at decreasing back pain than just doing light workouts. This treatment has been used to treat back pain in the past but the frequency level we are testing has not been well-studied before. This means that the HiVE treatment protocol is still considered to be experimental for the treatment of lower back pain.

Participation in this study will include 5-10 visits one visit per day on weekdays with each session lasting up to 30 minutes and will include TMS treatment (2-3 minutes) and completion of questionnaires (12-30 minutes) before and after treatment. Individuals in the sham group will be offered open label trail of the actual stimulation if the participants desires.

There will be 88 people taking part in the study over a period of 6 months and the overall pain scores as well as a functional activity score will be used to determine effectiveness between treatment and sham groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Edwards Air Force Base, California, United States, 93524
        • Recruiting
        • 412 Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with chronic low back pain (greater than or equal to 12 weeks) with or without concurrent neck pain.
  • Low back pain in the paraspinal region (L1-S2) by asking the patient to point to their area of pain.
  • 18 - 64 years old (on the day of informed consent)
  • Willing and able to attend all study visits.
  • No medication changes for at least 30 days before study enrollment (self-report)
  • Eligible for care at participating military treatment facilities
  • Able to read and understand English.
  • Negative pregnancy test for women capable of pregnancy.

Exclusion Criteria:

  • Diagnosed with low back pain of less than 12 weeks duration
  • History of back fractures or surgical repair of the back
  • History of depression with vagus nerve stimulation
  • Any type of transcranial magnetic stimulation (TMS), or rPMS treatment prior to study enrollment.
  • Currently using any other adjunctive treatments for chronic back pain such as low-level laser treatment, ultrasound, dry needling, chiropractor manipulations, cervical collars, TENS units, or other stimulation, eastern medicine regimens including Qi Gong or Tai Chi. (Exception: strength building physical therapy, non-neuropathic pain modifiers, and non-anticonvulsant routine pain medicine regimens such as NSAIDS and Acetaminophen are allowed).Scheduled for nerve ablation, dry needling, trigger point injections, nerve block, therapeutic ultrasound, other stimulation, or similar adjunct treatments during the study period.
  • Diagnosed with a specific low back pain: osteoarthritis, rheumatoid arthritis, phantom limb pain, central pain syndrome, spinal cord damage, myofascial pain syndrome, or other more specific diagnosis (at investigators discretion).
  • Unstable or poorly controlled mental health diagnosis (e.g., current changes in medication or medical management).
  • Dermal or subdermal implants (e.g., aneurysm clips, shunts, stimulators, ferro magnetic implants, stents, or electrodes, or pacemakers) or any other metal object within or near the site of stimulation which cannot be safely removed.
  • Clinically significant abnormality or clinically significant unstable medical condition that, in the investigator's judgment, might pose a potential safety risk to the subject or limit interpretation of the trial results.
  • Any condition which, in the judgment of the investigator, would prevent the patient from completing study procedures.
  • Pregnancy
  • Younger than 18 years old (on the day of informed consent)
  • Older than 64 years old (on the day of informed consent)
  • NOT willing or able to attend all study visits.
  • Medication changes for back pain less than 30 days prior to study enrollment (self-report)
  • NOT eligible for care at participating military treatment facilities
  • NOT able to read and understand English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Individuals in this arm receive magnetic stimulation to the area of the lower back where they have pain from sessions 1 through 5. We begin stimulation operation at 20% advancing in 5% increments to maximum of 35% machine power which in our case is approximately 0.3 tesla to 0.58 tesla of power (a typical outpatient MRI is 1.5 to 3 tesla). The power of the unit will be titrated up to the maximum 35% based on patient tolerance by asking participants to "Tell me if you feel a painful muscle contraction". Patients receiving active therapy would be able to feel the stimulus usually described as a vibration sensation. If patients report painful muscle contractions, stop and go back by 5%. Doing this helps ensure that we would not cause any potentially painful muscle contractions and avoid confounding our test data. The first treatment will start at 20% power then increase by 5% until the titrated power level is identified, subsequent treatments will start at the power level last used.
Device: peripheral magnetic stimulation
Our stimulation protocol is ssing approximately 0.3 tesla to 0.58 tesla of magnetic power using a variable stimulation frequency between 11ms and 14ms with center value of 13ms between pulses. This translates to estimated values of lower bounds of 71.43 Hz, central value of 83 Hz, and maximum value of 99 Hz .
Other Names:
  • rPMS
  • magnetic stimulation
  • repetitive magnetic stimulation
  • repetitive peripheral magnetic stimulation
Behavioral: Home exercise
All patients will receive a home exercise guide and recommended to perform the stated number of repetitions of those exercises. Exercises include Neutral Curl Up with Straight Leg, Plank on Elbow, and Bird Dog positions.
Other Names:
  • back pain exercises
  • home physical therapy
  • Neutral Curl Up with Straight Leg
  • Plank on Elbow
  • Bird Dog
Sham Comparator: Sham Arm

The investigators will configure the rPMS device to not utilize any power, then place the treatment wand over the participant's back pain area and hit the start button like they do in the treatment arm. When the power setting is set to zero, the magnetic wand will not generate any power but will still make the customary computer-generated tones as it does in normal operation. The device is set to play a completed tone once 2 minutes and 30 seconds have elapsed just as it does in the normal treatment. The investigator will then replace the wand back to the storage position and notify the patient that the session is completed.

Following completion of 5 sessions, the sham group will be offered to receive up to 5 sessions of real rPMS stimulation. The data from the sham treatment and real rPMS treatment for these patients will be tracked separately.
Behavioral: Home exercise
All patients will receive a home exercise guide and recommended to perform the stated number of repetitions of those exercises. Exercises include Neutral Curl Up with Straight Leg, Plank on Elbow, and Bird Dog positions.
Other Names:
  • back pain exercises
  • home physical therapy
  • Neutral Curl Up with Straight Leg
  • Plank on Elbow
  • Bird Dog

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention
Visual Analog Scale or VAS is a common self reported pain measurement scale from 0 - 100 with 0 being pain free and 100 being most pain possible.
VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ODI
Time Frame: Scores are obtained at: Baseline, pre-intervention. Immediately after intervention session 2 Immediately after intervention session 5 Immediately after intervention session 10 for those that elect to opt in for open label portion of study
Oswestry Disability Index (ODI) is a set of questions used to identify participant's functional status as related to activities of daily living.
Scores are obtained at: Baseline, pre-intervention. Immediately after intervention session 2 Immediately after intervention session 5 Immediately after intervention session 10 for those that elect to opt in for open label portion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joe X. Zhang

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joe Zhang, MD, United States Air Force

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDG20240078H
  • 23S005 (Other Grant/Funding Number: 711 HPW Studies and Analysis Branch)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

measured variables such as VAS and ODI scales for the study along with power tolerated by de-identified individuals using participant ID only can be shared.

IPD Sharing Time Frame

Will be available at the conclusion of data collection (estimated Nov 2026) and be available for up to 2 years (Nov 2028)

IPD Sharing Access Criteria

De-identified data can be made available upon request. Data is stored on secured government systems and cannot be actively reviewed without permission and assistance from investigation team. A formal request needs to be coordinated with the research team to be able to gain access to the data sheets.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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