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Recruiting NCT07652944

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

Conditions: Lower Back Pain Chronic

Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 88
Sponsor: Joe X. Zhang

Location: 412 Medical Group Edwards Air Force Base California

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07652944). StuddyBuddy aggregates publicly available trial information.