Mobile Neurofeedback for Low Back Pain
Effective Self-Management of Chronic Pain With mHealth Neurofeedback
Duke University
150 participants
Oct 2, 2023
INTERVENTIONAL
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
Inclusion Criteria3
- Responding greater than 3 months to "How long has low back pain been an ongoing problem for you?"
- 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 Criteria6
- History of seizures.
- Planning pain-related surgery in the next 9 months.
- Individuals with implanted medical devices that could experience interference during EEG and/or ECG, such as a spinal cord stimulator or pacemaker.
- Lower back pain is associated with compensation or litigation issues.
- Rating of past week pain intensity<4 on 0-10 point scale.
- Rating of past week pain interference<4 on 0-10 point scale.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05669027