Peripheral Transcutaneous Magnetic Stimulation for Chronic Pain

Overseen By Associate Professor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must be taking: Pain medications

Must not be taking: Methadone, Buprenorphine

Disqualifiers: Implanted devices, Infections, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 week

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how peripheral transcutaneous magnetic stimulation (pTMS) can relieve chronic pain, particularly pain persisting after surgery or an injury. The researchers aim to determine if pTMS can enhance the body's natural pain relief chemicals and reduce inflammation. Individuals with ongoing pain from past surgery or trauma, who experience this pain more than once a week and currently use pain medication, may be suitable candidates. Participants will undergo pTMS treatment for four days, during which their pain levels and biological markers will be measured to understand the treatment's effects.

As an unphased trial, this study provides a unique opportunity to explore innovative pain relief methods.

Will I have to stop taking my current medications?

You won't have to stop taking your current pain medications, as the trial allows participants to continue them. However, you cannot use other types of medications, except for certain therapies like methadone or buprenorphine for opioid addiction.

What prior data suggests that the pTMS device is safe for chronic pain treatment?

A previous study found peripheral transcutaneous magnetic stimulation (pTMS) to be safe and well-tolerated. The FDA has already cleared this device for managing chronic pain, supporting its safety profile. Other research shows that magnetic stimulation on nerves can effectively relieve pain without major side effects. This suggests that pTMS is generally safe for treating chronic pain. However, some individuals might not respond to the treatment, and minor discomfort could occur during pain testing. Overall, the risks are considered minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Peripheral Transcutaneous Magnetic Stimulation (PTMS) is unique because it offers a non-invasive approach to managing chronic pain, unlike standard treatments like opioids, NSAIDs, or surgery. PTMS works by using magnetic fields to stimulate nerves at the pain site, which may help modulate pain signals more directly and potentially offer relief without the side effects associated with medications. Researchers are excited about PTMS because it targets pain through an innovative method that could show results in just a few days, offering quicker relief compared to traditional therapies that often require weeks to take effect.

What evidence suggests that this pTMS device is effective for chronic pain?

Research has shown that peripheral transcutaneous magnetic stimulation (pTMS) may help relieve chronic pain. In one study, 62.5% of participants experienced a significant reduction in pain when pTMS was combined with other treatments. Another study found that two-thirds of patients saw an 87% decrease in pain and reduced their opioid use. Other trials reported that 70.0% to 81.4% of participants experienced less pain and improved quality of life. This trial will specifically evaluate pTMS for participants with post-traumatic or post-surgical chronic pain, suggesting that pTMS could effectively manage chronic pain. ^{1 2 4 6 7}

Who Is on the Research Team?

Patricia Junquera, MD

Principal Investigator

Florida International University and Baptist Health South Florida

Eduardo Icaza, MD

Principal Investigator

Baptist Health South Florida

Saurabh Aggarwal, MD., PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for 50 people with chronic pain from surgery or injury. Participants will be chosen based on pain and mental health assessments, as well as their response to heat, cold, and pressure tests. They must be willing to undergo blood tests before and after the therapy.

Inclusion Criteria

I have long-term pain in my limbs due to injury or surgery.

I am currently taking pain medication.

I have had pain in my arms or legs more than once a week for the last 3 months.

Exclusion Criteria

Implanted Electronic Devices and / or Conductive Objects in or near the head

Non-Removable Metallic Objects near the coil

Positive Urine Drug test for specified substances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo pTMS therapy at the site of pain for four consecutive days, with blood collection and pain testing on the first and last days.

1 week

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through phone calls every 30 days until the study's completion.

4 weeks

Phone follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral Transcutaneous Magnetic Stimulation

Trial Overview The study is testing a device called peripheral transcutaneous magnetic stimulation (pTMS) by MagVenture for four days to see if it can relieve chronic pain. Researchers will measure changes in substances related to pain in the blood before and after treatment.

How Is the Trial Designed?

Group I: Post-traumatic or post-surgical chronic pain Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Baptist Health South Florida

Collaborator

Trials

54

Recruited

8,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409336/

Efficacy and Safety of Magnetic Peripheral Nerve Stimulation ... Of these, a profound (>80%) reduction of pain was experienced by 62.5% of participants in the CMM + mPNS group, and 38.5% in the Crossover group ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023000718

Effect of Peripheral Magnetic Stimulation on Acute and ... Our results suggest that PMS was superior to sham or no-intervention in reducing acute and subacute postoperative pain, however there was no differences on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10350402/

Magnetic Peripheral Nerve Stimulation (mPNS) for Chronic Pain Two-thirds of patients, deemed responders, showed an 87% reduction in pain. Opioid reduction was seen in 58.3% of responders as well. Conclusion.

4. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(25)00138-2/fulltext

Safety and Efficacy of Magnetic Peripheral Nerve ... Pain relief, sensation, and QoL improvements were shown with high confidence. Pain responder rates ranged from 70.0% to 81.4%, a level ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejp.4763

Effects of multiple transcranial magnetic stimulation ... Current clinical trials indicate that repetitive transcranial magnetic stimulation (rTMS) is effective in reducing drug-resistant neuropathic pain (NP).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07199361

Uncovering the Mechanism of Pain Relief by Peripheral ... This research aims to uncover the Mechanisms of pain relief through the FDA-cleared peripheral transcutaneous magnetic stimulation (pTMS) ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK526087/

Peripheral Magnetic Stimulation - StatPearls - NCBI Bookshelf Since both PMS and TMS have similar physics properties, the safety data of TMS is referenced. ... Post-traumatic Peripheral Neuropathic Pain. A case series ...