Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation

NCT07199361 | Recruiting FDA Device

• 1 other identifier: IRB-25-0065
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Surgical Pain, Chronic; Post-traumatic Pain, Chronic

Keywords

Peripheral Transcutaneous Magnetic Stimulation; Post-Traumatic and Post-Surgical Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Pressure Pain Assessment

  Pressure Pain Threshold. A handheld probe (Algomed, Medoc) with a small (less than ½ inch wide) rubber tip will be used to apply pressure to the participant's forearm and shoulder. The pressure will slowly increase, and the participant will be asked to click a button when they first feel pain as a result of the pressure stimulation. The pressure will be removed as soon as the participant presses this button. This particular algometer will be used because it provides the examiner with visual feedback to maintain a consistent application rate, which is critical for maintaining high inter-examiner reliability. To assess the pressure pain threshold, the examiner will apply a constant rate of pressure, and the participant will be instructed to press a button when the sensation first becomes painful, at which time the device records the pressure in kilopascals. Higher kilopascals would suggest less pressure pain.

  1. On Day 1 (Baseline) 2. On Day 4 (post therapy)

• Thermal (Heat) pain

  Thermal (Heat) (Threshold, pain, and tolerance) will be assessed using TSA2 Air device from Medoc: A slowly increasing heat stimulus that the participant can terminate by pressing a button when it becomes painful or intolerable. The participant would press the button when they first feel warm (threshold), pain, or can no longer tolerate the heat. Lower heat indices indicate higher thermal sensitivity.

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

• Thermal (Cold) Pain

  Thermal (Cold) (Threshold, pain, and tolerance) will be assessed using TSA2 Air device from Medoc: A slowly decreasing cold stimulus that the participant can terminate by pressing a button when it becomes painful or intolerable. The participant would press the button when they first feel cold (threshold), pain, or can no longer tolerate the cold. Higher cold indices indicate higher thermal sensitivity.

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

• Temporal Heat Summation

  Temporal heat summation will be measured using TSA2 Air device. A series of 5 brief heat pulses (about 2 seconds in duration) will be given, and the participant will be asked to rate how painful each heat pulse feels on a scale from 0 to 100. These heat pulses will be repeated at different temperatures (44° C, 46° C, and 48° C). The participant can stop the procedures at any time so that they do not experience unacceptable pain. Greater pain ratings indicate more pain

  1. On day 1 (Baseline) 2. On Day 4 (Post therapy)

• Conditioned Pain Modulation

  Conditioned pain modulation (CPM) will be tested by TSA2 Air Device. The standard thermode will be placed on the left hand, and the heat pain rating will be assessed at 46 degrees. Then the right hand will be immersed in cold water for 30 seconds. The Heat pain test will be performed again on the left hand to assess Pain modulation. A normal response would indicate a decrease in heat pain on the left hand after immersing the right hand in cold water.

  1. On day 1 (Baseline) 2. On day 4 (Post Therapy)

Secondary Outcomes (10)

• McGill Pain Questionnaire-Short Form

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

• Brief Pain Inventory

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

• Present Pain Index

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

• Visual Analogue scale

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

• PHQ-9

  1. On day 1 (Baseline) 2. On day 4 (Post therapy)

Study Arms (1)

Post-traumatic or post-surgical chronic pain

EXPERIMENTAL

Arm Description: 50 Participants with post-surgical or post-traumatic chronic pain below the neck will be administered peripheral transcutaneous magnetic stimulation at the site of pain for 13 minutes for 4 consecutive days. Participants will be male or female between the ages of 19 and 80 years.

Device: Peripheral Transcutaneous Magnetic Stimulation from MagVenture

Interventions

Peripheral Transcutaneous Magnetic Stimulation from MagVenture DEVICE

MagVenture Pain Therapy System: It is an FDA-cleared magnetic stimulator system that provides brief and focused magnetic pulses to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic, and post-surgical pain for patients 18 years or older. It is a relatively new technique in the US for pain relief in the clinical setting and thus not very widespread yet. Evidence shows Magnetic Peripheral Nerve Stimulation to have a promising average pain relief of up to 87%\*. Using magnetic pulses, MagVenture Pain Therapy engages sensory, pain, and motor fibers mechanistically to recondition the central nervous system by eliminating noxious pain signals to the brain, reducing chronic neuropathic pain for responsive patients. \*Bedder M, Parker L.: Magnetic Peripheral Nerve Stimulation (mPNS) for Chronic Pain, 2023

Post-traumatic or post-surgical chronic pain

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Currently receiving pain medication Chronic pain must self-report peripheral pain, more than once per week, for at least three consecutive months
• 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.
• 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

Sponsors & Collaborators

• Florida International University: lead
• Baptist Health South Florida: collaborator

Study Sites (1)

Ambulatory Care Center, Florida International University

Miami, Florida, 33199, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Saurabh Aggarwal, MD., PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

• Patricia Junquera, MD

  Florida International University and Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

• Eduardo Icaza, MD

  Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Professor

CONTACT

305-348-9634; saaggarw@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a "pre vs. post" pTMS therapy, a one-group pretest-posttest study model. In this model, all the study participants will undergo pTMS for 4 consecutive days, and the changes in the mediators of chronic pain in plasma, serum, and peripheral immune cells will be measured in therapy responders and non-responders before pTMS and again after pTMS. The goal is to see if the intervention caused a change in the outcome within that same group.

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 30, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): January 25, 2028
• Study Completion (Estimated): February 25, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)