Digital therapy for chronic back pain
Healing Track Randomized Clinical Trial
This study is testing a new digital therapy for chronic back pain to see if it works better than regular treatments for helping people feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06641102 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a digital pain reprocessing therapy (PRT) for individuals suffering from chronic back pain (CBP). Participants will be randomized into three groups: one receiving a self-guided digital program, another receiving a coach-assisted program, and a control group receiving standard of care interventions. The study aims to compare the effectiveness of the digital therapy against traditional treatment methods in reducing pain intensity. A total of 180 adults aged 21 to 70 with chronic back pain will be enrolled in the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 70 who have been experiencing chronic back pain for at least three months.
Not a fit: Patients with back pain related to compensation or litigation issues, or those whose leg pain is greater than their back pain, may not benefit from this study.
Why it matters
Potential benefit: If successful, this digital therapy could provide a more effective and accessible treatment option for patients with chronic back pain.
How similar studies have performed: Other studies have shown promise in using digital therapies for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai - Abilities Research Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: David Putrino, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Alexandra Canori, DPT, PhD
- Email: alexandra.canori@mountsinai.org
- Phone: (212)-241-8454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.