Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-04 @ 3:11 PM
Study NCT ID:
NCT02421757
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2015-04-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: