Healing Track Clinical Trial
This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP). The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienc
| Condition(s) | Chronic Back Pain |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP). The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP. This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of |
| Who can participate | Inclusion Criteria: * Aged 21 to 70 * Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force * Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months. * Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week). * Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner. * Able to use a smartphone Exclusion Criteria: * Back |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Locations | New York, New York, United States |
| Start date | 2025-05-12 |
| NCT ID | NCT06641102 |
| Official listing | https://clinicaltrials.gov/study/NCT06641102 |