Healing Track Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Icahn School of Medicine at Mount Sinai - Abilities Research Center
RECRUITING
New York
Contact Information
Primary
Alexandra Canori, DPT, PhD
alexandra.canori@mountsinai.org
(212)-241-8454
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 180
Treatments
Experimental: Participants with Chronic Back Pain in Self-Guided Program
Participants with CBP in a self-guided program that includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules.
Experimental: Participants with Chronic Back Pain in Coach Assisted Program
Participants with CBP in a one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually.
Active_comparator: Participants receiving Standard of Care
Standard of care (SOC) control group in adults with CBP.
Related Therapeutic Areas
Sponsors
Collaborators: Healing Track
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov