Mobile Neurofeedback for Low Back Pain

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05669027
Status
Recruiting
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Conditions

  • Chronic Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

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.
  • 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).

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Dec 2025
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Condition
    Mobile Neurofeedback intervention arm
  • Placebo Comparator: Control Condition
    Sham-control arm

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical Center, Department of PsychiatryDurhamNorth Carolina27705
Eric Elbogen
[email protected]
919-684-9983
Eric Elbogen, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University Medical Center, Department of Psychiatry· Durham, NC

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