Computerized Chemosensory Training for Chronic Low Back Pain
This study is testing a new approach called Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) for people with chronic low back pain. It uses a special device with beta-caryophyllene, a natural compound, to help reduce pain. Researchers will compare this to a similar device that gives off continuous smells but without beta-caryophyllene. The goal is to see how well CBOT-P works to improve pain intensity and mood over 1 to 3 months. You may be able to join if you are 18-85 years old, have had pain for over 6 months, and your low back pain is your main pain, with an average pain score of more than 5 out of 10. The study is currently recruiting 220 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a randomized clinical trial, comparing two different interventions.
- What's involved
- The study measures pain intensity and mood at the start, and then again at 1 month and 3 months. Specific procedures or tests beyond these measurements are not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 3 months after starting the study interventions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Charles Nwaokobia · PRINCIPAL_INVESTIGATOR · Evon Medics LLC
- Evaristus Nwulia, MD, MHS · PRINCIPAL_INVESTIGATOR · Evon Medics LLC
- Tanya Alim, MD · PRINCIPAL_INVESTIGATOR · Howard University
- Haddi Ogunsola, MD · PRINCIPAL_INVESTIGATOR · Global Pain Management, LLC
Who to contact
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What this trial measures
- Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)Baseline to month 1 visit
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline. The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
- Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)Baseline to month 1 visit
Change in negative affect score from the PANAS rating scale It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
- Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)Baseline to month 3 visit
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline. The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
- Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)Baseline to month 3 visit
Change in negative affect score from the PANAS rating scale It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
- Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)Baseline to month 6 visit
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline. The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
- Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)Baseline to month 6 visit
Change in negative affect score from the PANAS rating scale It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
- Grey Matter Volumes of OrbitoFrontal Cortex and Hippocampus Aim 2.2Baseline and 6 months
Change in the structural brain MRI baseline grey matter volumes of the orbitofrontal cortex and hippocampus at 6 months. The investigators will use linear mixed effect and coefficient measures, and include sex, age, opioid medications, and duration of CP as confounders and as effect modifiers. Investigators will also estimate linear and non-linear trajectories.