Healing Track Clinical Trial for Chronic Back Pain

This study is testing new digital treatments for chronic back pain (CBP). Researchers want to see if a smartphone application, either a self-guided program (Tier 1) or a coach-assisted program (Tier 3), can help reduce pain as effectively as standard medical care. You might be able to join if you are between 21 and 70 years old and have chronic back pain that has lasted at least three months. The main goal is to measure changes in your pain intensity over time. The study is currently recruiting 180 participants, but its overall status is unclear.

Study design
This is a randomized clinical trial, meaning participants will be assigned to one of the treatment groups by chance. It aims to enroll 180 participants.
What's involved
Participants will use a smartphone application, either a self-guided program with videos and worksheets, or a coach-assisted program with weekly hour-long Zoom sessions. Pain levels will be measured at several points over about 8.5 months.
Compensation
Not stated in the trial record.
Follow-up
Pain intensity will be measured at various times, with the last measurement at 8.5 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06641102

Healing Track Clinical Trial

Recruiting
NAAges 21–70InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~180 participants
Updated 2025-07-18 on ClinicalTrials.gov
What's tested:Self-Guided Program (Tier 1)Coach Assisted Program (Tier 3)Standard of Care (SOC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brief Pain Inventory Short Form
Measured over <Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5
Chronic Back Pain
1 sites across 1 states
New York1
  • David Putrino, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

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
  • Brief Pain Inventory Short Form<Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5

    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)