Transcranial Direct Current Stimulation for Chronic Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: sham transcranial direct current stimulation; Device: transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham tDCS; 10 sessions sham transcranial direct current stimulation (tDCS)	Device: sham transcranial direct current stimulation; sham stimulation
Experimental: active tDCS; 10 sessions active transcranial direct current stimulation (tDCS)	Device: transcranial direct current stimulation; active stimulation: 2 milliamp (mA), 20 mins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating	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).	8 weeks total
Pain Anxiety Symptom Scale Rating	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.	8 weeks total

Collaborators and Investigators

• Sponsor: Butler Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 4, 2018

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1411-003