NCT06641102 · Icahn School of Medicine at Mount Sinai
Healing Track Clinical Trial
What this study is about
This is a randomly assigned 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).
View original scientific description
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 all potential interventions that are recommended for an individual. The research team plans to enroll 180 participants who will be randomized into one of three groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 pain associated with compensation or litigation issues as determined by self-report within the past year
- Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
- Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
- Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder
- Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations