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Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)

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ClinicalTrials.gov Identifier: NCT02421757
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Rock, University of Maryland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lower Back Pain Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device Device: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
Actual Study Start Date : August 22, 2016
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Transcutaneous Magnetic Stimulation
Transcutaneous Magnetic Stimulation
Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device
Transcutaneous Magnetic Stimulation

Placebo Comparator: Sham
Sham
Device: Placebo
The placebo Transcutaneous device
Other Name: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)




Primary Outcome Measures :
  1. Immediate pain relief (Numeric Pain Scale (NPRS) [ Time Frame: 60 minutes ]
    Immediate pain relief measured by Numeric Pain Scale (NPRS)


Secondary Outcome Measures :
  1. Durable pain measured by Numeric Pain Scale (NPRS) [ Time Frame: 30 days ]
    Durable pain relief



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421757


Locations
United States, Maryland
La Toya Stubbs
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland

Responsible Party: Peter Rock, Professor of Anesthesiology, University of Maryland
ClinicalTrials.gov Identifier: NCT02421757     History of Changes
Other Study ID Numbers: HP-00062233
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Peter Rock, University of Maryland:
Transcutaneous Magnetic Stimulation
placebo

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms