Healing Track Clinical Trial

Last updated: May 10, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Back Pain

Chronic Pain

Chronic Musculoskeletal Pain

Treatment

Self-Guided Program (Tier 1)

Standard of Care (SOC)

Coach Assisted Program (Tier 3)

Clinical Study ID

NCT06641102
STUDY-24-00080
  • Ages 21-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Aged 21 to 70

  • Chronic Back Pain- CBP will be defined according to the criteria established by arecent NIH task force

  • Pain duration must be at least 3 months, with back pain being an ongoing problem forat least half the days of the last 6 months. That is, patients can meet criteria byeither reporting pain every day for the past 3 months, or by reporting pain on halfor more of the days for the past 6+ months.

  • Patients must rate pain intensity at 4/10 or greater on the Brief PainInventory-Short Form (BPISF) (on the item measuring average pain over the lastweek).

  • Participants must also be comfortable and able to communicate via email or textmessage, as several study measures are collected in this manner.

  • Able to use a smartphone

Exclusion

Exclusion Criteria:

  • Back pain associated with compensation or litigation issues as determined byself-report within the past year

  • Leg pain is greater than back pain, as this suggests neuropathic pain, which may beless responsive to psychotherapy

  • Cauda Equina syndrome, as screened for by self-reported inability to control bowelor bladder function

  • Self-reported diagnoses of schizophrenia, multiple personality disorder, ordissociative identity disorder

  • Self-reported use of intravenous drugs, due to concerns about infections and subjectcompliance with experimental protocols

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Self-Guided Program (Tier 1)
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Icahn School of Medicine at Mount Sinai - Abilities Research Center

    New York, New York 10029
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.