Transcranial Direct Current Stimulation for Chronic Low Back Pain

B

Butler Hospital

Status

Completed

Conditions

Chronic Low Back Pain

Treatments

Device: sham transcranial direct current stimulation
Device: transcranial direct current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02768129
1411-003

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

sham tDCS
Sham Comparator group
Description:
10 sessions sham transcranial direct current stimulation (tDCS)
Treatment:
Device: sham transcranial direct current stimulation
active tDCS
Experimental group
Description:
10 sessions active transcranial direct current stimulation (tDCS)
Treatment:
Device: transcranial direct current stimulation

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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