NCT05669027

Mobile Neurofeedback for Low Back Pain

Effective Self-Management of Chronic Pain With mHealth Neurofeedback

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed 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 interference, pain self-efficacy, drug and alcohol use, opioid use, drug/alcohol use; a physical function test; and an EEG. Participants will be be randomly assigned to either an experimental (mobile neurofeedback) or placebo-control (sham neurofeedback) group. All participants will receive a portable Muse EEG headset and an iPod Touch with a mobile app named 'Mobile Neurofeedback' and 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. The control condition involves a visually identical mobile app yoked to a pre-recorded set of actual neurofeedback sessions (i.e., placebo). Study coordinators will conduct 6 check in calls in the intervening period, the study team will to reinforce training, troubleshoot technical problems, and assess any risk/safety issues (weeks 1,3,5,7,9, and 11). Follow-up data will 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, a physical function test, and an EEG. Data will be collected at baseline, 3, 6, and 9 months.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DEVICE	Neurofeedback	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.
DEVICE	Sham (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).

Timeline

• Start date: 2023-10-02
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2022-12-30
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study