Healing Track Clinical Trial

Healing Track Randomized 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 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Back Pain
• Intervention / Treatment: Other: Self-Guided Program (Tier 1); Other: Coach Assisted Program (Tier 3); Other: Standard of Care (SOC)

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra Canori, DPT, PhD; Phone Number: (212)-241-8454; Email: alexandra.canori@mountsinai.org
• Study Contact Backup: Name: Sheri Cheng; Phone Number: 929-286-2935; Email: Sheri.Cheng@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai - Abilities Research Center
      • Principal Investigator: David Putrino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Self-Guided Program (Tier 1); The study intervention is a smartphone application. Tier 1: self-guided program, includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules. Two modules are delivered per week, with email reminders. It will emphasize that PRT is a practice that requires users to come back to the material regularly to help retrain the brain often (just like how you need to practice and complete exercises between PT sessions).
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.	Other: Coach Assisted Program (Tier 3); The study intervention is a smartphone application. Tier 3: one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually. Users will meet with the assigned coaches once per week for an hour-long Zoom-hosted session that covers the same information as Tier 1, however in a completely personal and individualized way, focusing on the content that is most relevant for the user/patient at the time of the session. Tier 3 users will also receive materials from their coaches (e.g. videos, meditations, etc.) to support their own practice between session.
Active Comparator: Participants receiving Standard of Care; Standard of care (SOC) control group in adults with CBP.	Other: Standard of Care (SOC); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory Short Form	A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Full scale from 0 to 10, with higher score indicating more pain symptoms. Minimum score: 0 (no pain) Maximum score: 10 (pain as bad as you can imagine)	<Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Healing Track
• Investigators: Principal Investigator: David Putrino, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: STUDY-24-00080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No