Digital therapy for chronic back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: Mackenzie Doerstling, MPH
• Email: CoreResearch@mountsinai.org
• Phone: (212) 241-8454

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Validation of the 2025 Axial Spondyloarthritis Classification Criteria in Chinese patients

  This study tests whether the 2025 ASAS-SPARTAN criteria correctly classify axial spondyloarthritis in adults with chronic back pain in China.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07724847

• Basivertebral Nerve Ablation for Axial Low Back Pain

  This trial tests whether monopolar basivertebral nerve ablation can reduce pain for adults with chronic axial low back pain who have certain MRI changes and have not benefited enough from other treatments.

  Recruiting EPC Education s.r.o. · Prague and 2 other locations · NCT07559890

• Percutaneous ear (auricular) vagus nerve stimulation plus standard rehabilitation for chronic back pain

  This will try adding tiny electrical stimulation to the outer ear (pVNS) alongside standard rehabilitation to see if adults with chronic back pain have less pain and better function.

  Recruiting Medical University of Vienna · Baden, Lower Austria · NCT07529392

• Sedation before ultrasound-guided spinal anesthesia to reduce back pain after surgery.

  This trial will test whether giving midazolam before ultrasound-guided spinal anesthesia lowers the chance of new or persistent back pain after elective lower abdominal or leg surgery in adults.

  Recruiting Benha University · Banhā, Qalyubia Governorate · NCT07198412

• Using focused ultrasound to treat chronic pain

  This study is testing if low-intensity focused ultrasound can help people with chronic back pain feel less pain by targeting a specific part of the brain.

  Recruiting Washington D.C. Veterans Affairs Medical Center · Washington D.C., District of Columbia · NCT06906211

• Using focused ultrasound to treat pain, anxiety, and opioid cravings

  This study is testing whether a new ultrasound treatment can help people with opioid use disorder, chronic back pain, and anxiety feel less pain, reduce anxiety, and curb cravings for opioids.

  Recruiting Washington D.C. Veterans Affairs Medical Center · Washington D.C., District of Columbia · NCT06453109

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.