Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorFlorida International University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Peripheral Transcutaneous Magnetic Stimulation from MagVenture
DeviceMagVenture 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
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Post-traumatic or post-surgical chronic painExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1. On Day 1 (Baseline) 2. On Day 4 (post therapy)2
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.
Time frame
1. On day 1 (Baseline) 2. On day 4 (Post therapy)3
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.
Time frame
1. On day 1 (Baseline) 2. On day 4 (Post therapy)4
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
Time frame
1. On day 1 (Baseline) 2. On Day 4 (Post therapy)Secondary outcomes
1
McGill Pain Questionnaire-Short Form
Description: 15 descriptors (11 sensory; 4 affective) using an intensity scale ranging from 0-3 on the pain scale (0 = no pain, 1 = mild pain, 2 = moderate pain, or 3 = severe pain) A higher number indicates more pain
Time frame
1. On day 1 (Baseline) 2. On day 4 (Post therapy)2
Brief Pain Inventory
A set of 4 Pain Questionnaire: Worst pain in last 24 hours: (1-10) Least pain in last 24 hours (1-10) Pain on average (1-10) Pain right now (1-10) Total possible score: 40 A higher number indicates more pain
Time frame
1. On day 1 (Baseline) 2. On day 4 (Post therapy)3
Present Pain Index
A pain score of current pain on the scale of 0-5 A higher number indicates more pain
Time frame
1. On day 1 (Baseline) 2. On day 4 (Post therapy)4
Visual Analogue scale
A visual pain scale of 1-100 A higher number indicates more pain
Time frame
1. On day 1 (Baseline) 2. On day 4 (Post therapy)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida International University
Lead sponsor
Baptist Health South Florida
Collaborator
Source ClinicalTrials.gov