The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain
NCT02483468 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2023-02-10
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
Interventions
- BEHAVIORAL
-
Cognitive Behavioral Therapy for Pain
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.
- DEVICE
-
Transcranial Direct Current Stimulation
Electrical stimulation of the prefrontal cortex using 2mA of direct current
- DEVICE
-
Sham Transcranial Direct Current Stimulation
Sham stimulation of the left dorsolateral prefrontal cortex
Sponsors & Collaborators
-
Medical University of South Carolina
lead OTHER
Principal Investigators
-
Jeffrey J Borckardt, Ph.D. · Medical University of South Carolina
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2021-04-28
- Completion
- 2021-04-28
Countries
- United States
Study Locations
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