N/A
N=20
Treatment of Back Pain Using Transcutaneous Magnetic Stimulation (TCMS)
Lower Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02421757 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Immediate Pain Measured by Numeric Pain Rating Scale (NPRS) — 4.89; 5.18 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (Device); Placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Pain Measured by Numeric Pain Rating Scale (NPRS) |
4.89; 5.18 | — |
| SECONDARY Durable Pain Measured by Numeric Pain Rating Scale (NPRS) |
6.00; 6.57 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult, age >18 years of age
- Prescription pharmacologic treatment is insufficient for treatment of pain
- Pain duration of ≥ 6 months
- Pain limits physical activity
- Pain occurs daily
- 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
- Pain intensity ≥ 5 at the time of enrollment a a self-reported pain score of ≥ 4 over the 7 preceding days.
Exclusion Criteria
- Life expectancy ≤ 6 months for any reason
- Oral opiate dosing or type of opioid that has changed in past 12 months
- Received intraspinal (e.g., epidural, intrathecal) medication in the past 6 months
- Use of intravenous pain medication in the past 6 months
- Active use of a transcutaneous electrical nerve stimulator (TENS) [within 30 days]
- History of seizures
- History of implanted medical device, cardiac pacemaker or implantable cardiac defibrillator, or other implant (Cochlear etc)
- History of cardiac dysrhythmias
- Member of vulnerable population
- Current or potential legal action of disability claim related to back pain
- Body Mass Index (BMI) >35
- Another pain condition that might confound results, including back pain above the waistline
- Women of child-bearing potential
- Inability to undergo study assessments or complete questionnaires independently
- Metal objects in the body (i.e. Aneurysm clip, bullet fragment)
- Active psychological co-morbidites (i.e. uncontrolled schizophrenia)
Data sourced from ClinicalTrials.gov (NCT02421757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.