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Mobile Neurofeedback for Chronic Lower Back Pain (NINR Trial)

N/A
Recruiting
Led By Eric Elbogen, Ph.D.
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3, 6, and 9
Awards & highlights

NINR Trial Summary

This trial aims to learn how to improve treatment for chronic low back pain. Participants will use a mobile app and headset to train their brain to relax, 4x/week for 3 months. Researchers will check in with them 6 times via phone & video.

Who is the study for?
This trial is for people who have had ongoing lower back pain for more than three months and experience it on most days over the past six months. It's not suitable for those with a history of seizures, planned pain-related surgery soon, implanted medical devices like pacemakers that could be affected by EEG/ECG, or if their pain is tied to legal claims.Check my eligibility
What is being tested?
The study tests a mobile app and headset designed to train the brain towards relaxation as a treatment for chronic low back pain. Participants will use these tools four times weekly for three months and share feedback at set intervals throughout the study.See study design
What are the potential side effects?
Since this intervention involves neurofeedback via an app and headset without medication, side effects may include discomfort from wearing the device or emotional responses to neurofeedback but are generally expected to be minimal.

NINR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3, 6, and 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3, 6, and 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain intensity
Secondary outcome measures
Change in alpha brainwave (8 - 13 Hz) power as measured by EEG (electroencephalography)
Change in pain interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Change in physical function as measured by speed on the 50-foot walk test

NINR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ConditionExperimental Treatment1 Intervention
Mobile Neurofeedback intervention arm
Group II: Control ConditionPlacebo Group1 Intervention
Sham-control arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurofeedback
2019
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,411 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,700 Total Patients Enrolled
Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,492 Total Patients Enrolled

Media Library

Neurofeedback Clinical Trial Eligibility Overview. Trial Name: NCT05669027 — N/A
Chronic Lower Back Pain Research Study Groups: Experimental Condition, Control Condition
Chronic Lower Back Pain Clinical Trial 2023: Neurofeedback Highlights & Side Effects. Trial Name: NCT05669027 — N/A
Neurofeedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669027 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment criteria for this trial limit participation to those under 30 years of age?

"This clinical trial necessitates that all participants are between 18 and 90 years old, as stipulated in the enrolment parameters."

Answered by AI

Are there any openings left in this clinical trial?

"Per the records hosted by clinicaltrials.gov, recruitment for this study has been paused since 1/23/2023. However, there are currently 328 other medical trials actively seeking participants."

Answered by AI

What are the criteria for enrolling in this research program?

"This trial is open to 150 applicants who suffer from chronic lower back pain, ranging in age from 18 - 90. In order be eligible for the study, participants must have experienced low-back pain symptoms persisting longer than 3 months and occurring at least half of the days over a 6 month period. This requirement follows NIH Task Force on Research Standards for Chronic Low Back Pain's criterion recommendations."

Answered by AI

Who else is applying?

What site did they apply to?
Duke University Medical Center, Department of Psychiatry
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have had 5 discectomies, a neurostimulator put in and taken out and still have some moderate low back pain.
PatientReceived 2+ prior treatments
I have had chronic lower back pain for a number of years and have tried PT, ablation’ acupuncture, chiropractic, medicines, etc.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Mobile Neurofeedback for Low Back Pain
2023. "Mobile Neurofeedback for Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669027.
All > Chronic Low Back Pain > Lower Back Pain
~100 spots leftby May 2027
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