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

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.

Inclusion Criteria:

- Treatment-seeking OEF/OIF/OND Veterans (including National Guard and Reservists) ages
18 through 65

- Chronic Lower Back pain (ICD-9 Diagnosis code 724; BPI pain on average score>4/10; ≥3
months duration of pain)

- Prescription opiate use disorder (past 6 months; COMM score >13).

Exclusion Criteria:

- Latex Allergy

- Pregnant

- No current chronic lower back pain (3 months<)

- Not taking opiates/pain medication

- Psychiatric Condition Preventing successful engagement in CBT

- Current Medications that lower seizure threshold

- Other major medical problem (e.g., history of seizures)

- Unable or unwilling discontinue current behavioral therapy