How peripheral transcutaneous magnetic stimulation may relieve chronic post-surgical and post-traumatic pain
Official title: Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Run by Florida International University · NCT07199361 · Data updated 2026-11-12
This will try a FDA-cleared peripheral transcutaneous magnetic stimulation (pTMS) device on adults with chronic post-surgical or post-traumatic peripheral pain to see if it reduces pain and changes blood markers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Florida International University Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | March 24, 2025 |
| Main results expected | January 25, 2028 |
| Study ends | February 25, 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07199361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19–80 with confirmed chronic peripheral pain from trauma or surgery that occurs more than once per week for at least three months and who can attend in-person visits are ideal candidates.
✕Probably not a fit
People with central pain syndromes, pain lasting under three months, implanted electronic devices or non-removable metal near the coil, or those who simply do not respond to pTMS may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Fifty adults with chronic peripheral pain from surgery or trauma will complete pain and mental health questionnaires and undergo quantitative sensory testing to measure responses to heat, cold, and pressure. Blood samples will be taken before and after a four-day course of pTMS applied at the site of pain to analyze changes in plasma and leukocyte pain- and inflammation-related mediators. Pain testing and questionnaires will be repeated after treatment to compare functional and biomarker changes. The protocol excludes people with implanted electronic devices or non-removable metal near the stimulation coil.
Why it matters
Potential benefit: If successful, pTMS could offer a noninvasive, opioid-sparing option for reducing peripheral chronic pain and identify blood markers that track response.
How similar studies have gone: Related transcranial magnetic stimulation work and small peripheral TMS reports have shown some pain relief, but peripheral pTMS for chronic post-surgical or post-traumatic pain remains relatively novel and mechanistic evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of chronic peripheral pain secondary to trauma or surgery. Age 19 - 80; the lower end of this age range was chosen to capture young adults with pain, and participants over 80 years are increasingly likely to meet one or more exclusion criteria. Currently receiving pain medication Chronic pain must self-report peripheral pain, more than once per week, for at least three consecutive months Exclusion Criteria: * Implanted Electronic Devices and / or Conductive Objects in or near the head: Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: deep brain stimulators, cochlear implants, and vagus nerve stimulators). Non-Removable Metallic Objects near the coil: Patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (examples: cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, and bullet fragments). F NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients. Active microbial infections may alter the quantity or quality of blood inflammatory cells such as monocytes and neutrophils. Positive Urine Drug test: (COC/AMP/OPI/mAMP/PCP/BAR/BZO/MTD/MDMA/OXY/PPX/BUP/TCA) Use of any medication other than pain medications. However, participants will not be excluded or asked to withdraw from medications used for pain management since temporary withdrawal from these medications could affect pain measures (exceptions will be therapies such as methadone or buprenorphine used to treat opioid addiction). Only those who have been stable on these medications for at least 60 days will be included. All patient medications used for at least 60 days prior to participation will be recorded and controlled in statistical analyses as needed. Systemic rheumatic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus). These rheumatologic conditions will be excluded due to their autoimmune characteristic. Cachexia (wasting syndrome) and severe frailty as determined by the Groningen Frailty Index (score \>4). This exclusion is in place to protect against the stress of experimental pain testing. Uncontrolled hypertension (i.e. SBP/DBP of \>140/90) or cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals. Poorly controlled diabetes (HbA1c \> 8%) for both safety reasons and because diabetic neuropathy could alter pain perception. Neurological disease (e.g. Parkinson's, multiple sclerosis). Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation. Any participant deemed to be actively suicidal upon study screening will be escorted to the emergency room and evaluated by the Psychiatry Service. A diminished cognitive function that would interfere with the understanding of study procedures. The Mini-Mental Status Exam (MMSE) will be administered to ensure that participants are free of cognitive impairment that would compromise study participation. MMSE \<18 will be excluded. Pregnancy
Where it's running
-
Ambulatory Care Center, Florida International University
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Saurabh Aggarwal, MD., PhD — Florida International University
- Study coordinator: Associate Professor
- Email: saaggarw@fiu.edu
- Phone: 305-348-9634
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.