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Behavioural Intervention
Computerized Brain Training for Lower Back Pain (CBOT-P-2 Trial)
Phase 2
Recruiting
Led By Evaristus Nwulia, MD, MHS
Research Sponsored by Evon Medics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-85
Pain duration > 6 months
Must not have
Non-ambulatory status
Back surgery within the past six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and month 6
Summary
This trial aims to study the effectiveness of a computer-based training program called CBOT-P for treating Chronic Low Back Pain. The study will compare CBOT-P to a sham training program to see if it
Who is the study for?
This trial is for individuals with chronic low back pain who are interested in a non-drug treatment. Participants should be willing to undergo brain scans and complete various assessments. Specific details about age, health conditions, or other criteria aren't provided here.
What is being tested?
The study tests a computerized training called CBOT-P designed to reduce pain by targeting the brain's orbitofrontal cortex. It will be compared to a sham (fake) version of the training to see if it truly works over time.
What are the potential side effects?
Since this intervention is behavioral therapy using computerized tasks, there may not be traditional side effects like with medications; however, participants might experience discomfort from sitting during sessions or fatigue from concentration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Select...
My pain has lasted for more than 6 months.
Select...
My average pain level is above 5/10, mainly in my lower back.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot walk by myself.
Select...
I have not had back surgery in the last 6 months.
Select...
I haven't started new pain or psychiatric treatments in the last 2 weeks.
Select...
I have lost my sense of smell or have a significant nasal condition.
Select...
I have had a stroke or traumatic brain injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and month 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Grey Matter Volumes of OrbitoFrontal Cortex and Hippocampus Aim 2.2
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Secondary study objectives
California Verbal Learning Test (CVLT) Aim 2.1
Grey matter volumes of the cingulate cortex and other prefrontal cortex regions Aim 2.2
Patient Global Impression of Change Aim 2.1
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBOT-P [CBOT + beta caryophyllene (BCP)]Experimental Treatment1 Intervention
CBOT device with BCP
Group II: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)Placebo Group1 Intervention
CBOT device
Find a Location
Who is running the clinical trial?
Georgetown UniversityOTHER
350 Previous Clinical Trials
138,945 Total Patients Enrolled
1 Trials studying Low Back Pain
86 Patients Enrolled for Low Back Pain
Evon Medics LLCLead Sponsor
4 Previous Clinical Trials
776 Total Patients Enrolled
1 Trials studying Low Back Pain
86 Patients Enrolled for Low Back Pain
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,453 Total Patients Enrolled
15 Trials studying Low Back Pain
4,560 Patients Enrolled for Low Back Pain
Family and Medical Counseling Service, IncUNKNOWN
2 Previous Clinical Trials
390 Total Patients Enrolled
Global Pain Management, LLCUNKNOWN
Howard UniversityOTHER
43 Previous Clinical Trials
14,989 Total Patients Enrolled
1 Trials studying Low Back Pain
86 Patients Enrolled for Low Back Pain
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,468 Total Patients Enrolled
9 Trials studying Low Back Pain
1,098 Patients Enrolled for Low Back Pain
University of MarylandOTHER
169 Previous Clinical Trials
306,721 Total Patients Enrolled
Evaristus Nwulia, MD, MHSPrincipal InvestigatorEvon Medics LLC
Haddi Ogunsola, MDPrincipal InvestigatorGlobal Pain Management, LLC