NCT02421757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2017

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

November 23, 2021

Completed
Last Updated

November 23, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

April 10, 2015

Results QC Date

September 27, 2021

Last Update Submit

October 26, 2021

Conditions

Lower Back Pain

Keywords

Transcutaneous Magnetic Stimulationplacebo

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Durable Pain Measured by Numeric Pain Rating Scale (NPRS)

    30 days

Study Arms (2)

Transcutaneous Magnetic Stimulation

EXPERIMENTAL

Transcutaneous Magnetic Stimulation

Device: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device

Sham Device

PLACEBO COMPARATOR

Sham Device

Device: Placebo

Interventions

Fischell Transcutaneous Magnetic Stimulation Pain Treatment DeviceDEVICE

Transcutaneous Magnetic Stimulation

Transcutaneous Magnetic Stimulation
PlaceboDEVICE

The placebo Transcutaneous device

Also known as: Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device (TCMS Placebo)
Sham Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Toya Stubbs

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The population of patients (chronic pain) proved to be difficult to get in for treatment and follow-up. This lead to small enrollment numbers.

Results Point of Contact

Title
Dr. Peter Rock
Organization
University of Maryland School of Medicine
prock@som.umaryland.edu
410-328-6933

Study Officials

  • Peter Rock, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 21, 2015

Study Start

August 22, 2016

Primary Completion

June 22, 2017

Study Completion

June 22, 2017

Last Updated

November 23, 2021

Results First Posted

November 23, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)