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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 : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Rock, University of Maryland

April 10, 2015
April 21, 2015
September 28, 2017
August 22, 2016
June 22, 2017   (Final data collection date for primary outcome measure)
Immediate pain relief (Numeric Pain Scale (NPRS) [ Time Frame: 60 minutes ]
Immediate pain relief measured by Numeric Pain Scale (NPRS)
Immediate pain relief (Numeric Pain Scale (NPRS) [ Time Frame: < 60 minutes ]
Immediate pain relief measured by Numeric Pain Scale (NPRS)
Complete list of historical versions of study NCT02421757 on ClinicalTrials.gov Archive Site
Durable pain measured by Numeric Pain Scale (NPRS) [ Time Frame: 30 days ]
Durable pain relief
Durable pain measured by Numeric Pain Scale (NPRS) [ Time Frame: 2 days ]
Durable pain relief
Not Provided
Not Provided
 
Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
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.

Approximately one third of Americans suffer from acute and chronic pain and pain has been called a silent epidemic. Treatment of pain often involves opiod 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Lower Back Pain
  • Device: Transcutaneous Magnetic Stimulation
    Transcutaneous Magnetic Stimulation
    Other Name: TCMS
  • Device: Placebo
    The placebo TCMS device
    Other Name: TCMS Placebo
  • Experimental: Transcutaneous Magnetic Stimulation
    Transcutaneous Magnetic Stimulation
    Intervention: Device: Transcutaneous Magnetic Stimulation
  • Placebo Comparator: Sham
    Sham
    Intervention: Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
June 22, 2017
June 22, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02421757
HP-00062233
No
Not Provided
Plan to Share IPD: No
Peter Rock, University of Maryland
University of Maryland
Not Provided
Not Provided
University of Maryland
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP