Transcranial Direct Current Stimulation for Chronic Low Back Pain

NCT02768129 | Completed Results

• 1 other identifier: 1411-003
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

sham tDCS

SHAM COMPARATOR

10 sessions sham transcranial direct current stimulation (tDCS)

Device: sham transcranial direct current stimulation

active tDCS

EXPERIMENTAL

10 sessions active transcranial direct current stimulation (tDCS)

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

active stimulation: 2 milliamp (mA), 20 mins

active tDCS

sham transcranial direct current stimulation DEVICE

sham stimulation

sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Butler Hospital: lead

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

small sample (N=21), participants not stratified by premorbid anxiety levels, inability to guarantee optimal targeting of left dorsal anterior cingulate cortex (dACC) in all participants, inability to address laterality effects of pain perception

Results Point of Contact

• Title: Benjamin Greenberg
• Organization: Butler Hospital

bgreenberg@butler.org

(401) 455-6200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: November 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 4, 2018
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07