The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain
Condition: Chronic Low Back Pain; Opioid Use, Unspecified
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      As a result of sustained operations in Afghanistan and Iraq, an increasing number of U.S.
      military personnel and Veterans are in need of effective pain management treatment. Chronic
      low back pain (CLBP) is the most common pain condition among returning Veterans and is
      associated with high levels of opioid analgesic prescribing in VA clinics. Although opioids
      are effective for acute pain, they are not very effective as a long-term treatment strategy.
      Furthermore, opioids are associated with significantly increased risk of misuse, addiction,
      diversion, overdose and death. Consequently, there is a critical need for the development of
      alternative, effective treatments for CLBP that can be implemented in VA-based healthcare
      settings. The proposed study will answer critical questions regarding the ability of
      Transcranial Direct Current Stimulation (tDCS) to augment the effects of cognitive behavioral
      therapy (CBT) for pain, and elucidate possible mechanisms underlying improved outcomes. tDCS
      is inexpensive and highly portable, making it a very scalable tool to add to current CBT
      interventions within the VA healthcare system. This study has the particular advantages of
      building directly on positive preliminary findings among civilians and is being led by a
      multi-disciplinary team of experts who have successfully collaborated in the past and are
      uniquely qualified to implement this type of investigation. The primary objective of the
      proposed Stage II study is to evaluate the effects of CBT in combination with tDCS 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. Secondary
      objectives are to evaluate acute lab-based pain markers and neural correlates of improvement
      in chronic pain using quantitative sensory testing. In order to accomplish this the
      investigators are: using a manualized, evidence-based CBT intervention that is already
      widely-disseminated within the VA system; employing a randomized, between-groups,
      double-blind experimental design; and examining standardized, repeated, dependent measures of
      change in: (a) clinical outcomes such as pain, opioid and other substance use disorders
      (e.g., alcohol, illicit drugs, other prescription drugs), depression, anxiety, sleep and PTSD
      symptomatology; and (b) process variables such as participant satisfaction, quality of life
      and treatment retention. The results of this study will provide important information
      regarding two non-pharmacologic, evidence-based interventions (CBT and tDCS), and will help
      inform policies and programs to better serve the needs of U.S. military personnel, Veterans,
      and their families. The findings from this study may help reduce public health costs and
      morbidity/mortality associated with chronic pain and co-morbid prescription opiate use
      disorders among our nation's Veterans.
    

Intervention name(s): Cognitive Behavioral Therapy for Pain; Transcranial Direct Current Stimulation; Sham Transcranial Direct Current Stimulation
Intervention type(s): Behavioral; Device; Device
Intervention description(s): 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.; Electrical stimulation of the prefrontal cortex using 2mA of direct current; Sham stimulation of the left dorsolateral prefrontal cortex
Other intervention name(s): CBT; tDCS; Sham tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment