Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatments sham transcranial direct current stimulation, transcranial direct current stimulation
Sponsor Providence VA Medical Center
Start date October 2013
End date November 2016
Trial size 40 participants
Trial identifier NCT02771990, 2013-042

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Sham Comparator)
10 sessions sham transcranial direct current stimulation (tDCS)
sham transcranial direct current stimulation
sham stimulation
(Experimental)
10 sessions active transcranial direct current stimulation (tDCS)
transcranial direct current stimulation
2 milliamp (mA) 20 minutes

Primary Outcomes

Measure
West Haven-Yale Multidimensional Pain Inventory (affective subscale) rating
time frame: 8 weeks
Pain Anxiety Symptom Scale rating
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official 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
Principal investigator Frederick Burgess, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Providence VA Medical Center.