search
Back to results

Transcranial Magnetic Stimulation for Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or older
  • Patient with Chronic Low Back Pain
  • Meets minimum pain level criteria
  • Ability to perform the experimental Task and Procedures

Exclusion Criteria:

  • MRI contraindication if an MRI exam is required per protocol
  • TMS Contraindication
  • History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
  • Neurologic illness that would interfere with brain integrity
  • Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
  • Currently pregnant or planning to become pregnant.
  • On going legal action or disability claim.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TMS Parameter Condition 1 first

TMS Parameter Condition 2 First

Arm Description

Application of Transcranial Magnetic Stimulation

Application of Transcranial Magnetic Stimulation

Outcomes

Primary Outcome Measures

Change in Average Daily Pain
Compared to baseline pain report as provided by Visual Analogue Scale (VAS)
Change in Worst Daily Pain
As compared to baseline worst daily pain report provided on visual analogue scale (VAS)

Secondary Outcome Measures

Full Information

First Posted
February 4, 2014
Last Updated
August 5, 2015
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT02070016
Brief Title
Transcranial Magnetic Stimulation for Low Back Pain
Official Title
Clinical Applicaitons of Non-Invasive Brain Stimulation for the Treatment of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test whether non-invasive brain stimulation, such as Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic pain conditions. We will test various methods of TMS to identify a treatment approach that may reduce the symptoms of chronic pain for the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS Parameter Condition 1 first
Arm Type
Experimental
Arm Description
Application of Transcranial Magnetic Stimulation
Arm Title
TMS Parameter Condition 2 First
Arm Type
Experimental
Arm Description
Application of Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
Change in Average Daily Pain
Description
Compared to baseline pain report as provided by Visual Analogue Scale (VAS)
Time Frame
Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks)
Title
Change in Worst Daily Pain
Description
As compared to baseline worst daily pain report provided on visual analogue scale (VAS)
Time Frame
Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Patient with Chronic Low Back Pain Meets minimum pain level criteria Ability to perform the experimental Task and Procedures Exclusion Criteria: MRI contraindication if an MRI exam is required per protocol TMS Contraindication History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher. Neurologic illness that would interfere with brain integrity Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher. Currently pregnant or planning to become pregnant. On going legal action or disability claim.
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Transcranial Magnetic Stimulation for Low Back Pain

We'll reach out to this number within 24 hrs