Mobile Neurofeedback for Low Back Pain
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 Start (Actual) 2 October 2023
🗓️ Primary Completion (Estimated) 1 May 2027
✅ Study Completion (Estimated) 1 May 2027
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 December 2022
  • First Submitted that Met QC Criteria 20 December 2022
  • First Posted 30 December 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 October 2023
  • Last Update Posted 11 October 2023
  • Last Verified October 2023