Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2025-05-12
2026-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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).
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.
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.
Participants receiving Standard of Care
Standard of care (SOC) control group in adults with CBP.
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.
Interventions
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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).
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
No
Sponsors
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Healing Track
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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David Putrino
Professor
Principal Investigators
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David Putrino, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai - Abilities Research Center
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY-24-00080
Identifier Type: -
Identifier Source: org_study_id
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