Mobile Neurofeedback for Low Back Pain

NCT05669027 | Recruiting DMC FDA Device

• 2 other identifiers: Pro001089391R01NR019788-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Neurofeedback; Biofeedback; Mobile Device; chronic low back pain; Pain Intensity; Relaxation; mHealth; Opioid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in pain interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

  Months 3, 6, and 9

• Change in physical function as measured by speed on the 50-foot walk test

  Months 3, 6, and 9

• Change in alpha brainwave (8 - 13 Hz) power as measured by EEG (electroencephalography)

  Months 3, 6, and 9

Study Arms (2)

Experimental Condition

EXPERIMENTAL

Mobile Neurofeedback intervention arm

Device: Neurofeedback

Control Condition

PLACEBO COMPARATOR

Sham-control arm

Device: Sham (Placebo Control)

Interventions

Neurofeedback DEVICE

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.

Experimental Condition

Sham (Placebo Control) DEVICE

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).

Control Condition

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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."

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Duke University Medical Center, Department of Psychiatry

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Eric Elbogen, Ph.D.

  Duke - Professor in Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janequia Evans

CONTACT

919-681-1613; DBHTL@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: December 30, 2022
• Study Start: October 2, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)