title: A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management.
abstract: Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience.
  
  
  
  Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial. Eighty-four participants will be randomized (1:1) into a single-blind, 2×12 (group×time) controlled trial. A battery-powered direct and constant current stimulator (Soterix Medical Inc. 2014) delivers anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the right DLPFC. Active tDCS is applied by supplying a 2mA current for 20min/session over 10 sessions. Participants complete self-report and performance-based assessments on a weekly basis just prior to brain stimulation. Self-report assessments are collected via Chronic Pain Tracker version 3.6, an iPad interfaced application. The performance-based pain tolerance task is completed through the cold presser task.
  
  
  
  Interventions with cross-symptomatic therapeutic potential are absolutely essential in the context of CP, in which psychiatric comorbidity is the norm. Modalities that can be used in tandem with evidence-based, non-opioid therapies have the potential to have a synergistic effect, resulting in increased effectiveness of what have been modestly effective treatments to date.
authors.affiliation: The Menninger Clinic, Houston, TX, United States; Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.
authors.forename: G
authors.initials: G
authors.lastname: Janice Jimenez-Torres
authors.affiliation: The Menninger Clinic, Houston, TX, United States; Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.
authors.forename: Benjamin L
authors.initials: BL
authors.lastname: Weinstein
authors.affiliation: The Menninger Clinic, Houston, TX, United States; Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.
authors.forename: Cory R
authors.initials: CR
authors.lastname: Walker
authors.affiliation: The Menninger Clinic, Houston, TX, United States; Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.
authors.forename: J
authors.initials: J
authors.lastname: Christopher Fowler
authors.affiliation: The Menninger Clinic, Houston, TX, United States.
authors.forename: Philippa
authors.initials: P
authors.lastname: Ashford
authors.affiliation: Anesthesia and Perioperative Medicine, Medical University of South Carolina, Charleston, SC, United States; Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson Veterans' Affairs Medical Center, Charleston, SC, United States.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Borckardt
authors.affiliation: The Menninger Clinic, Houston, TX, United States; Psychiatry & Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States. Electronic address: amadan@menninger.edu.
authors.forename: Alok
authors.initials: A
authors.lastname: Madan
mesh_terms: D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D059350:Chronic Pain / Q000628:therapy*; D006801:Humans; D018710:Pain Clinics; D059408:Pain Management / Q000379:methods*; D017397:Prefrontal Cortex; D016037:Single-Blind Method; D065908:Transcranial Direct Current Stimulation / Q000379:methods*
chemical_list: D018712:Analgesics, Non-Narcotic
keywords: Chronic pain; Pain management; Serious mental illness; Somatic symptoms; Transcranial direct current stimulation