Healing Track Clinical Trial

NCT06641102 | Recruiting

• 1 other identifier: STUDY-24-00080
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Participants with Chronic Back Pain in Self-Guided Program

EXPERIMENTAL

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)

Participants with Chronic Back Pain in Coach Assisted Program

EXPERIMENTAL

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)

Participants receiving Standard of Care

ACTIVE COMPARATOR

Standard of care (SOC) control group in adults with CBP.

Other: Standard of Care (SOC)

Interventions

Self-Guided Program (Tier 1) OTHER

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).

Participants with Chronic Back Pain in Self-Guided Program

Coach Assisted Program (Tier 3) OTHER

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.

Participants with Chronic Back Pain in Coach Assisted Program

Standard of Care (SOC) OTHER

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.

Participants receiving Standard of Care

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Healing Track: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai - Abilities Research Center

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David Putrino, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Canori, DPT, PhD

CONTACT

(212)-241-8454; alexandra.canori@mountsinai.org

Sheri Cheng

CONTACT

929-286-2935; Sheri.Cheng@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study team will remain unblinded for study procedures. Statistical analysis will be performed by a statistician who is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: May 12, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)