Transcranial Magnetic Stimulation for Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Clinical Applicaitons of Non-Invasive Brain Stimulation for the Treatment of Chronic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02070016
• Other study ID #: 27678
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2014
• Last updated: August 5, 2015
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Average Daily Pain	Compared to baseline pain report as provided by Visual Analogue Scale (VAS)	Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks)	No
Primary	Change in Worst Daily Pain	As compared to baseline worst daily pain report provided on visual analogue scale (VAS)	Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks)	No