Healing Track Clinical Trial

Mount Sinai Health System

Status: Enrolling

Conditions: Chronic Back Pain

Treatments: Other: Self-Guided Program (Tier 1); Other: Coach Assisted Program (Tier 3); Other: Standard of Care (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06641102

STUDY-24-00080

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Participants with Chronic Back Pain in Self-Guided Program

Experimental group

Description:

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.

Treatment:

Other: Self-Guided Program (Tier 1)

Participants with Chronic Back Pain in Coach Assisted Program

Experimental group

Description:

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.

Treatment:

Other: Coach Assisted Program (Tier 3)

Participants receiving Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care (SOC)