Correction: Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/25291.].

Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND: Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE: In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS: We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology's novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. RESULTS: The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS: Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain's societal burden. Our study could help shape future research and development of these innovative approaches. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/25291.

An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19.

BACKGROUND: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. CONCLUSIONS: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.

"My Surgical Success": Effect of a Digital Behavioral Pain Medicine Intervention on Time to Opioid Cessation After Breast Cancer Surgery-A Pilot Randomized Controlled Clinical Trial.

OBJECTIVE: This study aims to assess the feasibility of digital perioperative behavioral pain medicine intervention in breast cancer surgery and evaluate its impact on pain catastrophizing, pain, and opioid cessation after surgery. DESIGN AND SETTING: A randomized controlled clinical trial was conducted at Stanford University (Palo Alto, CA, USA) comparing a digital behavioral pain medicine intervention ("My Surgical Success" [MSS]) with digital general health education (HE). PARTICIPANTS: A convenience sample of 127 participants were randomized to treatment group. The analytic sample was 68 patients (N = 36 MSS, N = 32 HE). MAIN OUTCOMES: The primary outcome was feasibility and acceptability of a digital behavioral pain medicine intervention (80% threshold for acceptability items). Secondary outcomes were pain catastrophizing, past seven-day average pain intensity, and time to opioid cessation after surgery for patients who initiated opioid use. RESULTS: The attrition rate for MSS intervention (44%) was notably higher than for HE controls (18%), but it was lower than typical attrition rates for e-health interventions (60-80%). Despite greater attrition for MSS, feasibility was demonstrated for the 56% of MSS engagers, and the 80% threshold for acceptability was met. We observed a floor effect for baseline pain catastrophizing, and no significant group differences were found for postsurgical pain catastrophizing or pain intensity. MSS was associated with 86% increased odds of opioid cessation within the 12-week study period relative to HE controls (hazard ratio = 1.86, 95% confidence interval = 1.12-3.10, P = 0.016). CONCLUSIONS: Fifty-six percent of patients assigned to MSS engaged with the online platform and reported high satisfaction. MSS was associated with significantly accelerated opioid cessation after surgery (five-day difference) with no difference in pain report relative to controls. Perioperative digital behavioral pain medicine may be a low-cost, accessible adjunct that could promote opioid cessation after breast cancer surgery.

Dynamic Quantitative Sensory Testing to Characterize Central Pain Processing.

Central facilitation and modulation of incoming nociceptive signals play an important role in the perception of pain. Disruption in central pain processing is present in many chronic pain conditions and can influence responses to specific therapies. Thus, the ability to precisely describe the state of central pain processing has profound clinical significance in both prognosis and prediction. Because it is not practical to record neuronal firings directly in the human spinal cord, surrogate behavior tests become an important tool to assess the state of central pain processing. Dynamic QST is one such test, and can probe both the ascending facilitation and descending modulation of incoming nociceptive signals via TS and CPM, respectively. Due to the large between-individual variability in the sensitivity to noxious signals, standardized TS and CPM tests may not yield any meaningful data in up to 50% of the population due to floor or ceiling effects. We present methodologies to individualize TS and CPM so we can capture these measures in a broader range of individuals than previously possible. We have used these methods successfully in several studies at the lab, and data from one ongoing study will be presented to demonstrate feasibility and potential applications of the methods.