Chronic Low Back PainNINRNCT05669027
Mobile Neurofeedback for Low Back Pain
A study testing Neurofeedback in people with Chronic Low Back Pain, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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."
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center, Department of Psychiatry
Durham, North Carolina, 27705
Eric Elbogen, 919-684-9983, vetstudy@duke.edu
Eric Elbogen, PhD
About this study
Official title: Effective Self-Management of Chronic Pain With mHealth Neurofeedback
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.
Read the detailed description
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Neurofeedback, Sham (Placebo Control)
- Keywords
- Neurofeedback, Biofeedback, Mobile Device, chronic low back pain, Pain Intensity, Relaxation, mHealth, Opioid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackDevice
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 group | Role | What they receive |
|---|---|---|
| Experimental Condition | Experimental | Mobile Neurofeedback intervention arm Receives: Device: Neurofeedback |
| Control Condition | Placebo comparator | Sham-control arm Receives: Device: Sham (Placebo Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Low back pain intensity on a 0-10 point rating scale, where higher scores indicate greater pain intensity.
Measured: Months 3, 6, and 9
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Months 3, 6, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start2 Oct 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Eric Elbogen, Ph.D., Principal investigator, Duke - Professor in Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669027
- Sponsor's protocol ID
- Pro00108939
- Other IDs
- 1R01NR019788-01A1
- Acronym
- NINR
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Self-Management of Chronic Pain With mHealth Neurofeedback
- ClinicalTrials.gov ID
- NCT05669027
- Acronym / sponsor ID
- NINR / Pro00108939
- Conditions
- Chronic Low Back Pain
- Keywords
- Neurofeedback, Biofeedback, Mobile Device, chronic low back pain, Pain Intensity, Relaxation, mHealth, Opioid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Experimental | Device: NeurofeedbackMobile Neurofeedback intervention arm |
| Control Condition | Placebo comparator | Device: Sham (Placebo Control)Sham-control arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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."
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackParticipants 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. | Device | Experimental Condition |
| 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). | Device | Control Condition |
Primary outcome
Change in pain intensity
Time frame: Months 3, 6, and 9
Low back pain intensity on a 0-10 point rating scale, where higher scores indicate greater pain intensity.
3 secondary outcomes
Change in pain interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Months 3, 6, and 9
Change in physical function as measured by speed on the 50-foot walk test
Time frame: Months 3, 6, and 9
Change in alpha brainwave (8 - 13 Hz) power as measured by EEG (electroencephalography)
Time frame: Months 3, 6, and 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Elbogen, Ph.D. principal investigator
Duke - Professor in Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Chronic Low Back Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janequia Evans (919-681-1613, DBHTL@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Months 3, 6, and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.