Healing Track Clinical Trial

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Oct 11, 2024

Keywords

ClinConnect Summary

The Healing Track Clinical Trial is researching a new digital therapy designed to help people with chronic back pain (CBP). The goal is to find out if this digital treatment can relieve pain as effectively as traditional methods, especially for individuals who haven't had success with other treatments. The study will involve 180 participants who will be randomly assigned to either receive the digital therapy or standard care from healthcare providers, which includes consultations and other recommended treatments.

To be eligible for this trial, participants should be between 21 and 70 years old, have been experiencing chronic back pain for at least three months, and rate their pain at 4 out of 10 or higher. They should also be comfortable using a smartphone and able to communicate via email or text. Importantly, the study is not open to individuals with certain conditions, such as severe leg pain or specific mental health diagnoses. Participants can expect to receive either the new digital therapy or standard treatment and will help researchers understand the best ways to manage chronic back pain.

Gender

ALL

Eligibility criteria

• 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