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
Joe X. Zhang
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.
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 p…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
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 Crite…
Interventions
- Deviceperipheral 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 .
- BehavioralHome 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.
Location
- 412 Medical GroupEdwards Air Force Base, California