Transcranial Direct Current Stimulation for Chronic Low Back Pain

The goal of this study is to investigate the role of central neural pathways in mediating chronic pain. The aim of the study is to test the effect of stimulating brain regions that are part of a network underlying central pain processing using a non-invasive brain stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have used tDCS to target both sensory related cortical areas and those important for higher-order representations of pain. This study will target brain regions important for the behavioral response to the chronic sensation of pain. The hypothesis is that stimulation of these brain regions can modulate not only the affective component of pain, but ultimately also improve functioning and quality of life. This hypothesis will be tested by treating study participants eighteen and older with chronic low back pain (CLBP) of greater than six months using tDCS. To be part of this study, participants must meet all the inclusion and exclusion criteria.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic Low Back Pain ≥ 6 months duration in the lumbar region, present more than half the days of the month, and on average be at a moderate level of severity in the last month
At least one trial of physician recommended medication (e.g. acetaminophen, NSAIDS, skeletal muscle relaxants)
Pre-existing opioid and non-opioid pain medication must be non-existent or stable (medications have not changed for one month)
Be able to understand, read and write English
If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method)

Exclusion criteria

Lifetime Diagnostic and Statistical Manual (DSM) IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
Current DSM-IV diagnosis of substance dependence for alcohol, sedative/hypnotic drugs, stimulants, cocaine
Current cancer, infection, or inflammatory arthritis
Broken skin or other lesions in the area of the electrodes
Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation
Presence of metal in the cranial cavity
Holes in the skull made by trauma or surgery
Pacemakers, medication pumps, and other implanted electronic hardware
Pregnancy

Treatment and study plan

Transcranial Direct Current Stimulation

Device

active stimulation: 2 milliamp (mA), 20 mins

Sham Transcranial Direct Current Stimulation

Device

sham stimulation

Primary outcomes

West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating

Time frame: 8 weeks total

Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome).
Pain Anxiety Symptom Scale Rating

Time frame: 8 weeks total

The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Official study title

tDCS for Chronic Low Back Pain: A Study Examining the Effect of Transcranial Direct Current Stimulation on the Emotional Response to Chronic Low Back Pain

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: May 11, 2016
Registry last updated: Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed