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RECRUITING
NCT05669027
NA

Mobile Neurofeedback for Low Back Pain

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: Effective Self-Management of Chronic Pain With mHealth Neurofeedback

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-10-02

Completion Date

2027-05-01

Last Updated

2025-12-17

Healthy Volunteers

Yes

Interventions

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).

Locations (1)

Duke University Medical Center, Department of Psychiatry

Durham, North Carolina, United States