Digital Therapy for Chronic Back Pain
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the research team for clarification.
What data supports the effectiveness of the treatment Digital Pain Reprocessing Therapy (PRT) for chronic back pain?
Is digital therapy for chronic back pain safe for humans?
How is Digital Pain Reprocessing Therapy different from other treatments for chronic back pain?
Digital Pain Reprocessing Therapy is unique because it uses digital technology to provide personalized, non-drug treatment for chronic back pain, focusing on changing how the brain processes pain. Unlike traditional treatments that may rely on medication or physical therapy alone, this approach integrates digital tools to enhance patient education and self-management, offering a flexible and home-based option.58111213
What is the purpose of this 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 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.
Research Team
David Putrino, PhD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
This trial is for adults with chronic back pain who haven't found relief from other treatments or have experienced side effects. Participants must be willing to try a digital therapy program and can follow either self-guided or coach-assisted modules, or receive standard care.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a digital pain reprocessing therapy intervention or standard of care for chronic back pain
Follow-up
Participants are monitored for changes in pain intensity and safety after treatment
Treatment Details
Interventions
- Digital Pain Reprocessing Therapy (PRT)
Digital Pain Reprocessing Therapy (PRT) is already approved in United States for the following indications:
- Chronic Back Pain
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Healing Track
Collaborator