(B-174) Transcending barriers to pain care in rural America: a pragmatic comparative effectiveness trial of evidence-based, on-demand, digital behavioral treatments for chronic pain

Background: More than 50 million Americans suffer from chronic pain. While pharmacotherapy plays a role in managing chronic pain, ineffectiveness, habituation, or addiction may limit some patients’ options.

Objectives: This decentralized, randomized controlled trial compared the effectiveness of two digital, evidence-based chronic pain management programs which utilized varying elements of CBT, distraction, and education: 3D immersive Skills-Based Virtual Reality (EaseVRx+) and a 2D mobile health application (painTRAINER).

Methods: Patients were recruited from 3 large health centers and practice networks. Patients meeting inclusion criteria (qualifying diagnostic code in medical record, rural primary residence ZIP code, aged 13+, ≥4 pain (scale: 0-10)) were identified in each site or network. Participants were screened by phone and consented to participate electronically. Participants completed a 7-day baseline survey which recorded demographics, and daily pain intensity and medication use prior to 1:1 randomization into the study arms. We measured improvement in pain intensity between baseline and week 8, defined by a minimally clinically important difference (MCID) of 2 points on the 11-point numeric rating scale (NRS). ITT analyses of the primary endpoint required responses to at least 4 of the 7 daily assessments. Secondary outcomes included PROMIS anxiety and pain interference, pain catastrophizing, and pain self-efficacy. Participants randomized to receive either an EaseVRx+ headset or were enrolled in the web-based painTRAINER program. Following randomization, participants completed 16 surveys collecting pain intensity, medication use, and other PROs over 12 weeks.

Results: A total of 330 participants were randomized; 169 to EaseVRx+ and 161 to painTRAINER. 278 participants completed the primary endpoint at Week 8, demonstrating high adherence to the study protocol. While patients improved in both arms (mean[SD] improvement of 1.22[1.48] units), the ITT analysis of the primary endpoint found no statistically significant difference in pain reduction between the EaseVRx+ (22.9% achieving MCID >=2) and painTRAINER arms (32.0%) (p = 0.088). The differences between the two arms in PROMIS Pain Interference, PROMIS Anxiety, and the Pain Catastrophizing Scale (PCS) between baseline and Week 8 were not significant. Pain Self-Efficacy was significantly greater in the painTRAINER arm at weeks 6, 7 and 8.

Conclusions: This trial displays the capability for digital health treatment modalities to surpass barriers to provide care in rural America. Both EaseVRx+ and painTRAINER are effective and accessible options to provide behavioral treatments for chronic pain, and could play a significant role to improve health equity in underserved populations.