The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain

NCT02483468 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00036590
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the effects of cognitive-behavioral therapy in combination with transcranial direct current stimulation in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity.

Conditions

Chronic Low Back Pain; Opioid Use, Unspecified

Outcome Measures

Primary Outcomes (3)

• Average Daily Pain

  Average daily pain defined by item #5 on the Brief Pain Inventory (BPI). Scale on scale of 0-10; anchored with "0-no pain" and "10- pain as bad as you can imagine."

  3 months

• Pain Interference

  Pain interference defined by the mean of items 9.a ---9.i; the measure is scored on a scale of 0--10, anchored by "0-does not interfere" and "10- completely interferes"

  3 months

• Pain Catastrophizing

  Pain catastrophizing defined by total score of 13 items pain catastrophizing scale. This measure has a total score range of 0-52 where for each item is anchored by "0-not at all" and "4-all the time." Larger total score indicates more catastrophizing.

  3 months

Secondary Outcomes (5)

• Opioid Misuse

  3 months

• Psychiatric Functioning (Depression)

  3 months

• Psychiatric Functioning (Anxiety)

  3 Months

• Psychiatric Functioning (PTSD)

  3 Months

• Psychiatric Functioning (Sleep)

  3 Months

Study Arms (2)

tDCS

EXPERIMENTAL

Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current

Behavioral: Cognitive Behavioral Therapy for Pain; Device: Transcranial Direct Current Stimulation

tDCS (sham)

SHAM COMPARATOR

Inactive (sham) Transcranial Direct Current Stimulation

Behavioral: Cognitive Behavioral Therapy for Pain; Device: Sham Transcranial Direct Current Stimulation

Interventions

Cognitive Behavioral Therapy for Pain BEHAVIORAL

Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities.

Also known as: CBT

tDCS; tDCS (sham)

Transcranial Direct Current Stimulation DEVICE

Electrical stimulation of the prefrontal cortex using 2mA of direct current

Also known as: tDCS

tDCS

Sham Transcranial Direct Current Stimulation DEVICE

Sham stimulation of the left dorsolateral prefrontal cortex

Also known as: Sham tDCS

tDCS (sham)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 70.
• United States Veteran or family member of a Veteran.
• Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
• Subjects must be able to comprehend English.
• Have a chronic pain condition and ≥3months duration of pain.
• BPI score \>4/10.
• Meet DSM-5 criteria for current (i.e., past 6 months) prescription opioid use disorder (assessed via the MINI 7.0).
• COMM score\>7.
• Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.
• Must consent to random assignment to CBT + tDCS or CBT + sham tDCS.
• Must consent to complete all treatment and follow-up visits.
• Must live within 100 miles of the Medical University of South Carolina.

You may not qualify if:

• Subjects with symptomatic psychotic/bipolar disorder and/or deemed too high risk by the study physician
• Subjects with current suicidal or homicidal ideation and intent.
• Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy in addition to the proposed therapy for stabilization.
• Subjects who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.
• Subjects enrolled in ongoing behavioral therapy for pain or substance use disorders, who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.
• Subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks. If it is determined, based on clinical criteria, that a subject needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the course of the study, they will be discontinued from the treatment trial.
• Subjects with organic mental syndrome.
• Pregnant women.
• History of seizures.
• Implanted medical devices above the waist.
• Latex allergy.
• Diagnosis of Fibromyalgia.
• History of eczema or other sensitive skin conditions.
• Known brain tumors or lesions that intersect the area of stimulation.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy; Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jeffrey J Borckardt, PhD
• Organization: Ralph H. Johnson VA Medical Center, Charleston, SC & Medical University of South Carolina

borckard@musc.edu

843.792.3295

Study Officials

• Jeffrey J Borckardt, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 29, 2015
• Study Start: August 1, 2015
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: February 10, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-01

Locations

US (1)