Mobile neurofeedback treatment for chronic low back pain
Effective Self-Management of Chronic Pain With mHealth Neurofeedback
This study is testing whether a mobile app that helps train the brain to relax can reduce chronic low back pain for people who suffer from it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05669027 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a mobile neurofeedback intervention for individuals suffering from chronic low back pain. Participants will engage in a double-blind randomized controlled trial, using a mobile app and EEG headset to train their brains to achieve a relaxed state. Over a period of 12 weeks, they will complete 10-minute sessions at least four times a week, while their pain levels and emotional states will be monitored. The study will assess outcomes through interviews and questionnaires at multiple time points throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced chronic low back pain for more than three months and report pain on at least half of the days over the past six months.
Not a fit: Patients with a history of seizures, those planning pain-related surgery, or individuals with implanted medical devices that may interfere with EEG will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce pain and improve the quality of life for patients with chronic low back pain.
How similar studies have performed: Previous studies have shown promise in using neurofeedback for pain management, suggesting that this approach may be effective, although this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Durham, North Carolina
- Duke University Medical Center, Department of Psychiatry — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Eric Elbogen, Ph.D. — Duke - Professor in Psychiatry and Behavioral Sciences
- Study coordinator: Janequia Evans
- Email: DBHTL@duke.edu
- Phone: 919-681-1613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.