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
Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
412 Medical Group
RECRUITING
Edwards Air Force Base
Contact Information
Primary
Joe Zhang, MD
joe.x.zhang.mil@health.mil
415-619-9997
Backup
Joshua Ford, PhysD
joshua.c.ford21.mil@health.mil
661-275-5057
Time Frame
Start Date:2026-07
Estimated Completion Date:2027-02
Participants
Target number of participants:88
Treatments
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.
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.