Mobile Neurofeedback for Low Back Pain

This is a double‐blind randomized controlled trial to test effects of mHealth mobileneurofeedback on the outcomes of pain, enrolling 150 adult participants (18 years of ageor older) with chronic low backpain. Participants will be scheduled for a baselineinterview at Dr. Elbogen's research office at Duke after a preliminary telephone screen.After providing informed consent, participants will complete an eligibility assessment, aphysical function test, self‐report questionnaire on pain interference including clinicalinterviews for health outcomes of pain; self‐report questionnaire on pain interference,pain self‐efficacy, drug and alcohol use, opioid use, drug/alcohol use; a physicalfunction test; and an EEG. Participants will be be randomly assigned to either anexperimental (mobile neurofeedback) or placebo‐control (sham neurofeedback) group. Allparticipants will receive a portable Muse EEG headset and an iPod Touch with a mobile appnamed 'Mobile Neurofeedback' and be asked to complete 10‐minute sessions at least 4 daysper week for 12 weeks. Participants will be asked to report their current level of pain,stress, and anger before and after each session. The experimental condition involves amobile app that provides auditory feedback signaling EEG alpha power above a thresholdlevel, denoting a physiologically relaxed state. The control condition involves avisually identical mobile app yoked to a pre‐recorded set of actual neurofeedbacksessions (i.e., placebo). Study coordinators will conduct 6 check in calls in theintervening period, the study team will to reinforce training, troubleshoot technicalproblems, and assess any risk/safety issues (weeks 1,3,5,7,9, and 11). Follow‐up datawill be collected upon completion of the intervention at 12 weeks, 24 weeks and 36 weeks.During all follow‐up visits, participants will complete self‐report questionnaires, aphysical function test, and an EEG. Data will be collected at baseline, 3, 6, and 9months.