Effective Self-Management of Chronic Pain With mHealth Neurofeedback
Duke University
Summary
The purpose of this study is to learn more about improving the quality of treatments for people who have chronic low back pain. Participants will complete interviews with Duke researchers at four different time points: the beginning of the study, at 3 months, at 6 months, and at 9 months. Participants will be asked to use a mobile app and a headset that are designed to train the brain to be more relaxed. Participants will use the mobile app for 10 minutes at a time, four times a week for three months. The study team will also check in with participants about app use six times throughout the study, via phone or video conference.
Description
This is a double-blind randomized controlled trial to test effects of mHealth mobile neurofeedback on the outcomes of pain, enrolling 150 adult participants (18 years of age or older) with chronic low backpain. Participants will be scheduled for a baseline interview at Dr. Elbogen's research office at Duke after a preliminary telephone screen. After providing informed consent, participants will complete an eligibility assessment, a physical function test, self-report questionnaire on pain interference including clinical interviews for health outcomes of pain; self-report questionnaire on pain…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Responding greater than 3 months to "How long has low back pain been an ongoing problem for you?" 2. Responding 'at least half the days' to "How often has low back pain been an ongoing problem for you over the past 6 months?" Investigators will follow recommendations to items and responses provided by the NIH Task Force on Research Standards for Chronic Low Back Pain, which specifically: "recommended 2 questions to achieve the definition of chronic low back pain: (1) How long has back pain been an ongoing problem for you? (2) How often has low back pain been an ongoing…
Interventions
- DeviceNeurofeedback
Participants will be asked to complete 10-minute sessions at least 4 days per 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 a mobile app that provides auditory feedback signaling EEG alpha power above a threshold level, denoting a physiologically relaxed state.
- DeviceSham (Placebo Control)
Participants will be asked to complete 10-minute sessions at least 4 days per week for 12 weeks. Participants will be asked to report their current level of pain, stress, and anger before and after each session. The control condition involves a visually identical mobile app yoked to a pre-recorded set of actual neurofeedback sessions (i.e., placebo).
Location
- Duke University Medical Center, Department of PsychiatryDurham, North Carolina