Recruiting

Mobile Neurofeedback

Sponsor:

Duke University

Code:

NCT05669027

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Neurofeedback

Sham (Placebo Control)

Study Details

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

Study ID

NCT05669027

Start date

Oct 2, 2023

Status verified date

Dec, 2025

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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/or ECG, such as a spinal cord stimulator or pacemaker.
4. Lower back pain is associated with compensation or litigation issues.
5. Rating of past week pain intensity<4 on 0-10 point scale.
6. Rating of past week pain interference<4 on 0-10 point scale.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Condition

Mobile Neurofeedback intervention arm

placebo comparator: Control Condition

Sham-control arm

Interventions

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.

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).

Primary outcome measure

  • Change in pain intensity [ Time Frame: Months 3, 6, and 9 ]

Central Contacts and Locations

Central contacts

Janequia Evans

919-681-1613DBHTL@duke.edu

Locations

Duke University Medical Center, Department of Psychiatry

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Eric Elbogen

919-684-9983vetstudy@duke.edu

Principal Investigator:

Eric Elbogen, PhD

More Information

Sponsor

Duke University

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-12-17.