Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)

This is a single-site, randomized, Single-blinded, placebo-controlled, trial of Transcutaneous Magnetic Stimulation (TCMS) for the treatment of lower back pain. TCMS will be applied locally to the back in the location of a patient's pain.

Study Overview

• Status: Completed
• Conditions: Lower Back Pain
• Intervention / Treatment: Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device; Device: Placebo

Detailed Description

Approximately one third of Americans suffer from acute and chronic pain and pain has been called a silent epidemic. Treatment of pain often involves opioid medications with a significant potential for abuse, addiction and adverse reactions such as respiratory depression and death. Magnetic brain stimulation has been used for the treatment of pain. There are reports of its use in phantom-limb pain and in the treatment of central and peripheral pain syndromes.

The study will evaluate whether an experimental medical device (Fischell TCMS Pain Treatment Device) that emits pulses of a brief, intense magnetic field will relieve pain in the lower back. Transcutaneous Magnetic Stimulation (TCMS) is the name of this method of delivering magnetic pulses through the skin. TCMS has been approved by the FDA for peripheral nerve stimulation, treatment of migraine headaches and for depression but this type of device has not been studied scientifically for the treatment of back pain. No significant adverse reactions or side effects have been reported with the use of magnetic stimulation for headache treatment. Some patients who have migraine headaches have excellent pain relief with the magnetic treatment even if they do not get pain relief with medications. Other patients do not have headache relief with magnetic treatment. The current use of TCMS applied to the head requires special equipment and multiple treatment sessions. TCMS applied peripherally is easier to do, and may require fewer treatment sessions to achieve pain relief. Non-invasive treatment of pain would represent a significant advance in the field especially if its use both successfully treated pain and resulted in the reduction or elimination in the need for opioid medications.

The investigators do not know whether magnetic treatment will relieve back pain so the investigators will test this by applying a powerful electromagnet to the area of the back having pain. In some patients, the magnet will be turned on, but in other patients the magnet will not be turned on. Neither patients nor patient's treating doctor will know whether the magnet was turned on or not, although the study team will know which patients received treatment with magnetic pulses. The effect on pain will be recorded periodically for 2 days. If the patients' reported pain is reduced by having the magnet turned on compared to patients' who do not have the magnet turned on, then the magnet may have reduced the pain. Additional studies in patients will be needed to be sure that the magnet therapy is reducing low back pain.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • La Toya Stubbs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult, age >18 years of age
2. Prescription pharmacologic treatment is insufficient for treatment of pain
3. Pain duration of ≥ 6 months
4. Pain limits physical activity
5. Pain occurs daily
6. Chronic low back pain, with or without leg pain, associated with MRI or other imaging study consistent with lumbo-sacral spine disease with or without nerve compression
7. Pain intensity ≥ 5 at the time of enrollment a a self-reported pain score of ≥ 4 over the 7 preceding days.

Exclusion Criteria:

1. Life expectancy ≤ 6 months for any reason
2. Oral opiate dosing or type of opioid that has changed in past 12 months
3. Received intraspinal (e.g., epidural, intrathecal) medication in the past 6 months
4. Use of intravenous pain medication in the past 6 months
5. Active use of a transcutaneous electrical nerve stimulator (TENS) [within 30 days]
6. History of seizures
7. History of implanted medical device, cardiac pacemaker or implantable cardiac defibrillator, or other implant (Cochlear etc)
8. History of cardiac dysrhythmias
9. Member of vulnerable population
10. Current or potential legal action of disability claim related to back pain
11. Body Mass Index (BMI) >35
12. Another pain condition that might confound results, including back pain above the waistline
13. Women of child-bearing potential
14. Inability to undergo study assessments or complete questionnaires independently
15. Metal objects in the body (i.e. Aneurysm clip, bullet fragment)
16. Active psychological co-morbidites (i.e. uncontrolled schizophrenia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Magnetic Stimulation	Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device; Transcutaneous Magnetic Stimulation
Placebo Comparator: Sham Device	Device: Placebo; The placebo Transcutaneous device; Other Names: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)	Immediate relief measured by Numeric Pain Rating Scale (NPRS) Scale from 0-10 0=No pain 10= Worse possible pain	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durable Pain Measured by Numeric Pain Rating Scale (NPRS)	Durable pain relief measured by Numeric Pain Rating Scale (NPRS) 0= No pain 10= Worse imaginable pain	30 days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Peter Rock, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2016
• Primary Completion (Actual): June 22, 2017
• Study Completion (Actual): June 22, 2017

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: placebo; Transcutaneous Magnetic Stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HP-00062233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes