Mobile Neurofeedback for Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effective Self-Management of Chronic Pain With mHealth Neurofeedback

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Neurofeedback
* Device: Sham (Placebo Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Examine effects of mobile neurofeedback on changes in pain intensity, pain interference, physical function, and EEG alpha (8-13 Hz) power. Examine mediating effect of self-efficacy on changes in pain outcomes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Condition<br>Mobile Neurofeedback intervention arm | Device: Neurofeedback<br>* 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.<br>|
| Placebo Comparator: Control Condition<br>Sham-control arm | Device: Sham (Placebo Control)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | Low back pain intensity on a 0-10 point rating scale, where higher scores indicate greater pain intensity. | Months 3, 6, and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System) | A higher PROMIS T-score indicates greater pain interference. The minimum score is 8 and the maximum score is 40. | Months 3, 6, and 9 | 
| Change in physical function as measured by speed on the 50-foot walk test | Participant is timed by how long it takes for them to walk 50 feet. | Months 3, 6, and 9 | 
| Change in alpha brainwave (8 - 13 Hz) power as measured by EEG (electroencephalography) | An EEG can identify and measure the electrical activity in the brain. Higher EEG alpha brainwave power indicates a greater state of relaxation. | Months 3, 6, and 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback, Biofeedback, Mobile Device, chronic low back pain, Pain Intensity, Relaxation, mHealth, Opioid