Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)

Lower Back Pain Clinical Trial

Official title:

Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421757
• Other study ID #: HP-00062233
• Status: Completed
• Phase: N/A
• Start date: August 22, 2016
• Est. completion date: June 22, 2017

Study information

• Verified date: October 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Device:
• Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device
Transcutaneous Magnetic Stimulation
• Placebo
The placebo Transcutaneous device

Locations

Country	Name	City	State
United States	La Toya Stubbs	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate Pain Measured by Numeric Pain Rating Scale (NPRS)	Immediate relief measured by Numeric Pain Rating Scale (NPRS); Scale from 0-10 0=No pain 10= Worse possible pain	60 minutes
Secondary	Durable Pain Measured by Numeric Pain Rating Scale (NPRS)	Durable pain relief measured by Numeric Pain Rating Scale (NPRS) 0= No pain 10= Worse imaginable pain	30 days