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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
Must not have
History of seizures
Rating of past week pain intensity<4 on 0-10 point scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3, 6, and 9
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures.
Select...
My pain level in the past week was less than 4 on a scale of 0 to 10.
Select...
My lower back pain is related to a legal or compensation matter.
Select...
My pain has not severely interfered with my daily activities in the past week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 3, 6, and 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3, 6, and 9
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain intensity
Secondary study objectives
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
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
~1110
Find a Location
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,623 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,108 Total Patients Enrolled
Duke UniversityLead Sponsor
2,452 Previous Clinical Trials
2,971,641 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.You have a medical device, like a pacemaker or spinal cord stimulator, that could be affected during the study tests.My pain level in the past week was less than 4 on a scale of 0 to 10.The study will use specific questions to determine if you have chronic low back pain. If you have had back pain for more than 3 months and it has been a problem for at least half the days in the past 6 months, you will be considered to have chronic low back pain.I've had low back pain on most days for the past 6 months.My lower back pain is related to a legal or compensation matter.I am planning to have surgery for pain in the next 9 months.My pain has not severely interfered with my daily activities in the past week.You have had ongoing low back pain for more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Condition
- Group 2: Control Condition
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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