Healing Track Clinical Trial

ConditionChronic Back Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-70

SponsorIcahn School of Medicine at Mount Sinai

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Self-Guided Program (Tier 1)
Other intervention
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)
Other intervention
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)
Other intervention
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.

Treatment groups

180 Participants

are divided into 3 treatment groups

Group A: Participants with Chronic Back Pain in Self-Guided ProgramExperimental treatment 1 intervention

Group B: Participants with Chronic Back Pain in Coach Assisted ProgramExperimental treatment 1 intervention

Group C: Participants receiving Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

<Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Healing Track

Collaborator

Source ClinicalTrials.gov

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