Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Train
The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain \[CBOT-Pain (or CBOT-P)\] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks Trai
| Condition(s) | Chronic Pain, Low Back Pain |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain \[CBOT-Pain (or CBOT-P)\] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) in Chronic Low Back Pain (CLBP) to determine its short- and long-term effectiveness on Pain, Negative Affect (NA), Cognition and Cortical Brain Structure (PACS), long-term safety, and indications. The investigators will perform a randomized clinical trial of the refined CBOT-P from Phase I, compared to sham CBOT in CLBP. Aim 2.1: To determine if CBOT-P significantly influences: (1) acute and long-term reduction of pain severity, and (2) acute and long-term reducti |
| Who can participate | 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 stu |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Evon Medics LLC |
| Locations | Washington D.C., District of Columbia, United States; Pasadena, Maryland, United States |
| Start date | 2024-10-23 |
| NCT ID | NCT06671132 |
| Official listing | https://clinicaltrials.gov/study/NCT06671132 |