Randomized Clinical Trial of Digital Pain Reprocessing Therapy for Chronic Back Pain Comparing Self-Guided, Coach-Led, and Standard Care Treatments in Adults 21 to 70 Years

What this Trial Is About

Researchers are evaluating a digital pain reprocessing therapy PRT for adults with chronic back pain CBP. This clinical trial aims to compare the effects of a new digital treatment to standard care, as some people with CBP have experienced side effects or insufficient relief from previous treatments. The study will measure changes in pain intensity among adults with CBP to see if digital therapy offers a viable alternative to traditional approaches. Participants will be randomly assigned to one of three groups a self-guided digital program with videos, meditations, and worksheets delivered in 10 modules a coach-assisted program with weekly one-on-one video sessions and personalized support or a standard of care group receiving comprehensive clinical care including consultation with a physiatrist and prescribed treatments. The self-guided program sends two modules per week and encourages regular practice, while the coaching group receives tailored guidance and materials. During the study, researchers will track pain intensity using the Brief Pain Inventory Short Form at multiple time points baseline, day 1, week 6, week 10, and month 8.5. Participants will use a smartphone for therapy and communication, with some measures collected via email or text. The study plans to enroll 180 adults aged 21 to 70, with ongoing monitoring throughout the treatment period to assess outcomes and safety.

Healing Track Clinical Trial