tDCS for Chronic Low Back Pain

NCT02771990 | Completed Results

• 1 other identifier: 2013-042
• 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

Keywords

Back Pain

Outcome Measures

Primary Outcomes (2)

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

  The WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity \[better\]).

  8 weeks

• Pain Anxiety Symptom Scale (PASS-20) Rating

  The PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety).

  8 weeks

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

Sham transcranial direct current stimulation DEVICE

sham stimulation

sham tDCS

transcranial direct current stimulation DEVICE

2 milliamp (mA) 20 minutes

active 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

• Providence VA Medical Center: lead

MeSH Terms

Conditions

Back Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

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

Results Point of Contact

• Title: Benjamin Greenberg
• Organization: Providence Veterans Affairs Medical Center

benjamin.greenberg@va.gov

4012737100

Study Officials

• Frederick Burgess, MD, PhD

  Providence VA Medical Center

  PRINCIPAL INVESTIGATOR

• Benjamin Greenberg, MD, PhD

  Providence VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, CfNN

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 13, 2016
• Study Start: October 1, 2013
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: March 29, 2023
• Results First Posted: May 4, 2021

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share