Training to reduce chronic pain using computerized olfactory techniques
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-Pain) Testing Phase
This study is testing a new computer-based training program to see if it can help adults with chronic low back pain feel better and improve their mood and thinking.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Evon Medics LLC Industry-sponsored |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06671132 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a novel Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT-P) designed to treat chronic low back pain (CLBP) by modulating brain networks associated with pain and negative affect. Participants will be randomly assigned to receive either the active CBOT-P intervention or a sham treatment, with the aim of assessing improvements in pain severity, mood, cognitive function, and brain structure over six months. The study seeks to establish a scalable, home-based solution for chronic pain management that is safe and effective. The trial will involve 220 adult patients and aims to provide evidence for the long-term benefits of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with chronic low back pain lasting more than six months and a pain score of over 5 out of 10.
Not a fit: Patients with acute suicidality, severe mental health disorders, or those with substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce chronic pain and improve overall mental health and cognitive function for patients suffering from CLBP.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using neuromodulatory techniques for pain management, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 18-85. 2. Pain duration \> 6 months. 3. Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener \>3. 4. Average pain score of \> 5/10, with low back pain being the primary pain site. (5) CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III. (6) Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture. (7) For those taking opioids (the opioid subgroup), participants must be prescribed opioids currently for at least 3 consecutive months prior to enrollment. Such patients must be on opioids for a minimum of three months, taking them daily or intermittently during the week. (8) Subject must agree that opioids cannot be increased during the study. (9) No substance use disorder (SUD), except tobacco in the past year based on substance screening survey and frequent urine toxicology screens. (10) No acute suicidality, mania, or psychosis. This will be assessed at study entry, which will also include a review of history in the EHR, Diagnostic Interview for Genetic Studies (DIGS) and Columbia Suicide Severity Rating scale (C-SSRS) and (11) Finally, participants must sign IRB-approved consent. Exclusion Criteria: 1. Back surgery within the past six months. 2. Active worker's compensation or litigation claims. 3. New pain and/or psychiatric treatments within 2 weeks of enrollment. 4. Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications. 5. Intent to add new psychiatric treatments during the first 3 months of the study. 6. Any clinically unstable systemic illness that is judged to interfere with the trial. 7. History of cardiac, nervous system, or respiratory disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for respiratory depression. 8. Non-ambulatory status. 9. Pregnancy or the intent to become pregnant during the study. Women of childbearing age will have urine pregnancy testing at enrollment and monthly. (10) Anosmia or significant nasal disease (11) Contraindications to MRI (12) Stroke or TBI (traumatic brain injury).
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Howard University — Washington D.C., District of Columbia, United States (Recruiting)
- Global Pain Management LLC — Pasadena, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Charles Nwaokobia — Evon Medics LLC
- Study coordinator: Evaristus Nwulia, M.D., MHS
- Email: enwulia@evonmedics.org
- Phone: 410-227-2005
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.