Brandon James Birckhead

All Publications

• Durable Chronic Low Back Pain Reductions to 24-Months Post-Treatment for An Accessible, 8-Week, In-Home Behavioral Skills-Based Virtual Reality Program: A Randomized Controlled Trial. Pain medicine (Malden, Mass.) Maddox, T., Sparks, C., Oldstone, L., Maddox, R., Ffrench, K., Garcia, H., Krishnamurthy, P., Okhotin, D., Garcia, L. M., Birckhead, B. J., Sackman, J., Mackey, I., Louis, R., Salmasi, V., Oyao, A., Darnall, B. D. 2023

  Abstract

  ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.RR2-10.2196/25291.

  View details for DOI 10.1093/pm/pnad070

  View details for PubMedID 37220894

• In-home virtual reality program for chronic low back pain: durability of a randomized, placebo-controlled clinical trial to 18 months post-treatment. Regional anesthesia and pain medicine Maddox, T., Garcia, H., Ffrench, K., Maddox, R., Garcia, L., Krishnamurthy, P., Okhotin, D., Sparks, C., Oldstone, L., Birckhead, B., Sackman, J., Mackey, I., Louis, R., Salmasi, V., Oyao, A., Darnall, B. 2022

  View details for DOI 10.1136/rapm-2022-104093

  View details for PubMedID 36427904

• Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial (vol 24, e37480, 2022) JOURNAL OF MEDICAL INTERNET RESEARCH Garcia, L., Birckhead, B., Krishnamurthy, P., Mackey, I., Sackman, J., Salmasi, V., Louis, R., Castro, C., Maddox, R., Maddox, T., Darnall, B. D. 2022; 24 (6)

  View details for Web of Science ID 000966321600004

• Correction: Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. Journal of medical Internet research Garcia, L., Birckhead, B., Krishnamurthy, P., Mackey, I., Sackman, J., Salmasi, V., Louis, R., Castro, C., Maddox, R., Maddox, T., Darnall, B. D. 2022; 24 (6): e40038

  Abstract

  [This corrects the article DOI: 10.2196/37480.].

  View details for DOI 10.2196/40038

  View details for PubMedID 35675658

• Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR research protocols Garcia, L., Darnall, B., Krishnamurthy, P., Mackey, I., Sackman, J., Louis, R., Maddox, T., Birckhead, B. 2021; 10 (1): e25291

  Abstract

  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.

  View details for DOI 10.2196/25291

  View details for PubMedID 33464215

• Double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain (during COVID-19). Journal of medical Internet research Darnall, B. n., Garcia, L. n., Birckhead, B. n., Krishnamurthy, P. n., Mackey, I. n., Sackman, J. n., Louis, R. n., Maddox, T. n. 2021

  Abstract

  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: 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 non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two 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.The study sample was 179 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx vs. Sham VR (p<0.0001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest p-value = .0090), and between-groups Cohen's 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 1.17-1.3 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 vs. the Sham VR group (p=0.0224 and p=.0132, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p<0.01) but not for ShamVR.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 non-pharmacologic treatment for chronic low back pain.ClinicalTrials.gov, NCT04415177.RR2-25291.

  View details for DOI 10.2196/26292

  View details for PubMedID 33484240

• Three-month follow-up results of a double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain. The journal of pain Garcia, L. M., Birckhead, B. J., Krishnamurthy, P., Mackey, I., Sackman, J., Salmasi, V., Louis, R., Maddox, T., Darnall, B. D. 2021

  Abstract

  Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to one of two 56-day VR programs: (1) a therapeutic immersive pain relief skills VR program; or (2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from drm = 0.56 to 0.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability and maintained superiority to Sham VR in the 3-month post-treatment period.

  View details for DOI 10.1016/j.jpain.2021.12.002

  View details for PubMedID 34902548

• Correction: Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR research protocols Garcia, L. M., Darnall, B. D., Krishnamurthy, P. n., Mackey, I. G., Sackman, J. n., Louis, R. G., Maddox, T. n., Birckhead, B. J. 2021; 10 (2): e27652

  Abstract

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

  View details for DOI 10.2196/27652

  View details for PubMedID 33577465

• Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR mental health Birckhead, B., Khalil, C., Liu, X., Conovitz, S., Rizzo, A., Danovitch, I., Bullock, K., Spiegel, B. 2019; 6 (1): e11973

  Abstract

  Therapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed.We aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments.A group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments.The interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided.Patients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.

  View details for DOI 10.2196/11973

  View details for PubMedID 30702436

  View details for PubMedCentralID PMC6374734

• Methodology for Clinical Trials of Virtual Reality in Healthcare: Recommendations from an International Working Group JMIR Mental Health Birckhead , B., et al 2018

  View details for DOI 10.2196/11973