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Recruiting NCT05669027

Mobile Neurofeedback for Low Back Pain

Trial Parameters

Condition Chronic Low Back Pain
Sponsor Duke University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2023-10-02
Completion 2027-05-01
Interventions
NeurofeedbackSham (Placebo Control)

Brief 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.

Eligibility Criteria

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 problem for you over the past 6 months? A response of greater than 3 months to question 1 and a response of 'at least half the days in the past 6 months' to question 2 would define chronic lower back pain." Exclusion Criteria: 1. History of seizures. 2. Planning pain-related surgery in the next 9 months. 3. Individuals with implanted medical devices that could experience interference during EEG and

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