Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)

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.

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)