Transcranial Direct Current Stimulation for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768129
• Other study ID #: 1411-003
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 4, 2018

Study information

• Verified date: July 2019
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 4, 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• transcranial direct current stimulation
active stimulation: 2 milliamp (mA), 20 mins
• sham transcranial direct current stimulation
sham stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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