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

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: Recruiting
• Conditions: Lower Back Pain Chronic
• Intervention / Treatment: Device: peripheral magnetic stimulation; Behavioral: Home 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: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joe Zhang, MD; Phone Number: 415-619-9997; Email: joe.x.zhang.mil@health.mil
• Study Contact Backup: Name: Joshua Ford, PhysD; Phone Number: 661-275-5057; Email: joshua.c.ford21.mil@health.mil

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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

Outcome Measure	Measure Description	Time Frame
ODI	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

• Sponsor: Joe X. Zhang
• Investigators: Study Director: Joe Zhang, MD, United States Air Force

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: lower back pain; magnetic stimulation; rPMS; repetitive peripheral magnetic stimulation; HiVE
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID 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