CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 160 enrolled
Drug / intervention
Cognitive Behavioral Therapy for Pain +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02483468
NCT02483468Phase 3Completed

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

Medical University of South Carolina·interventional·Posted Jun 29, 2015·Updated Feb 10, 2023

In Brief

A Phase 3 clinical trial evaluating Cognitive Behavioral Therapy for Pain, Transcranial Direct Current Stimulation, and 1 other intervention for Chronic Low Back Pain and Opioid Use, Unspecified. Completed, enrolled 160 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 29, 2015
Enrollment StartAug 1, 2015
Primary CompletionApr 28, 2021
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 11.0 years ago

Interventions

Cognitive Behavioral Therapy for Painbehavioral

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.

Transcranial Direct Current Stimulationdevice

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

Sham Transcranial Direct Current Stimulationdevice

Sham stimulation of the left dorsolateral prefrontal cortex