Actively Recruiting
Healing Track Clinical Trial
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-18
180
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
H
Healing Track
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Healing Track Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 to 70 years
- Chronic back pain lasting at least 3 months, with pain present at least half the days in the last 6 months
- Average pain intensity of 4 or greater on a 0-10 scale over the past week
- Comfortable and able to communicate via email or text message
- Able to use a smartphone
You will not qualify if you...
- Back pain related to compensation or litigation issues within the past year
- Leg pain greater than back pain, suggesting neuropathic pain
- Cauda Equina syndrome indicated by inability to control bowel or bladder function
- Diagnosed with schizophrenia, multiple personality disorder, or dissociative identity disorder
- Use of intravenous drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai - Abilities Research Center
New York, New York, United States, 10029
Actively Recruiting
Research Team
A
Alexandra Canori, DPT, PhD
CONTACT
S
Sheri Cheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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