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| ID | Type | Description | Link |
|---|---|---|---|
| 23S005 | Other Grant/Funding Number | 711 HPW Studies and Analysis Branch |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | 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. |
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| Sham Arm | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral magnetic stimulation | Device | 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 . |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joe Zhang, MD | Contact | 415-619-9997 | joe.x.zhang.mil@health.mil | |
| Joshua Ford, PhysD | Contact | 661-275-5057 | joshua.c.ford21.mil@health.mil |
| Name | Affiliation | Role |
|---|---|---|
| Joe Zhang, MD | United States Air Force | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 412 Medical Group | Recruiting | Edwards Air Force Base | California | 93524 | United States |
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.
Will be available at the conclusion of data collection (estimated Nov 2026) and be available for up to 2 years (Nov 2028)
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2026 | Jun 11, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2026 | Jun 11, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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single blind study where the sham group will be offered the treatment modality after having gone through 5 sham treatments. The treatment group will receive treatment but due to ability to feel the stimulations, it would not be possible to blind them for sham tests after receiving treatments.
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The test is single blind because the investigators will have to manipulate the treatment device so they will know what the settings are. Only participants that have not experienced magnetic stimulation can be blinded to the study.
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| Home exercise | Behavioral | 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. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |