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

Official title

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

Overview

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.

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.

Interventions

• 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 .
• 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.

Primary outcome measures

• Visual Analog Scale [Time frame: VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention]

Secondary outcome measures (1)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• 412 Medical Group — Edwards Air Force Base

Identifiers

NCT: NCT07652944 · FDG20240078H · 23S005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗