About this trial
This research aims to uncover the Mechanisms of pain relief through the FDA-cleared peripheral transcutaneous magnetic stimulation (pTMS) device by MagVenture. 50 people with chronic pain (post-surgical or post-traumatic) will be identified and recruited. The eligibility for participation in the study will be evaluated by a series of pain and mental health questionnaires followed by quantitative sensory testing (QST) to assess response to noxious heat, cold, and pressure stimuli. Blood will be drawn to isolate plasma, serum, and leukocytes. Participants will then undergo pTMS at the site of pain for four consecutive days. At the end of the therapy, pain testing will be done again, followed by blood withdrawal to assess the changes in plasma and leukocyte levels of mediators of pain. It is anticipated that pTMS will increase mediators of pain relief and reduce inflammatory mediators. Risks: It is possible that a few participants may not respond to pTMS therapy. However, plasma analysis of mediators of pain may help stratify these participants into responders vs. non-responders. Risks associated with the study are minimal and mainly involve discomfort associated with pain testing. The importance of knowledge gained includes understanding pain relief mechanisms by medical devices such as pTMS, which will result in better pain management.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Peripheral Transcutaneous Magnetic Stimulation from MagVenture
Treatment groups
Sponsors and collaborators
Florida International University
Lead sponsor
Baptist Health South Florida
Collaborator