Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02421757|
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Back Pain||Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device Device: Placebo||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Transcutaneous Magnetic Stimulation
Transcutaneous Magnetic Stimulation
Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device
Transcutaneous Magnetic Stimulation
Placebo Comparator: Sham
The placebo Transcutaneous device
Other Name: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)
- Immediate pain relief (Numeric Pain Scale (NPRS) [ Time Frame: 60 minutes ]Immediate pain relief measured by Numeric Pain Scale (NPRS)
- Durable pain measured by Numeric Pain Scale (NPRS) [ Time Frame: 30 days ]Durable pain relief
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
|United States, Maryland|
|La Toya Stubbs|
|Baltimore, Maryland, United States, 21201|