Laura Martínez García|Brandon Birckhead|Parthasarathy Krishnamurthy|Josh Sackman|Ian Mackey|Robert G. Louis|Vafi Salmasi|Todd Maddox|Beth D. Darnall
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
University of Houston|Hoag Memorial Hospital Presbyterian|Neurosciences Institute|Stanford University|Stanford University
background chronic low back pain prevalent chronic pain condition worldwide access behavioral pain treatment limited virtual reality vr immersive technology may provide effective behavioral therapeutics chronic pain objective aimed conduct doubleblind parallelarm singlecohort remote randomized placebocontrolled trial selfadministered behavioral skillsbased vr program communitybased individuals selfreported chronic low back pain covid19 pandemic methods national online convenience sample individuals selfreported nonmalignant low back pain duration 6 months average pain intensity 4 more10 enrolled randomized 11 1 2 daily 56day vr programs 1 easevrx immersive pain relief skills vr program 2 sham vr 2d nature content delivered vr headset objective device use data selfreported data collected primary outcomes betweengroup effect easevrx versus sham vr across time points betweenwithin interaction effect representing change average pain intensity painrelated interference activity stress mood sleep time baseline endoftreatment day 56 secondary outcomes global impression change change physical function sleep disturbance pain selfefficacy pain catastrophizing pain acceptance pain medication use user satisfaction analytic methods included intentiontotreat mixedmodel framework results study sample 179 adults female 765 137179 caucasian 905 162179 least college education 911 163179 mean age 515 years sd 131 average pain intensity 510 sd 12 back pain duration 5 years 67 120179 group differences found baseline variable treatment engagement user satisfaction ratings higher easevrx versus sham vr plt001 betweengroups factor easevrx superior sham vr primary outcomes highest p value009 betweengroups cohen effect sizes ranged 040 049 indicating superiority moderately clinically meaningful easevrx large prepost effect sizes ranged 117 13 met moderate substantial clinical importance reduced pain intensity painrelated interference activity mood stress betweengroup comparisons physical function sleep disturbance showed superiority easevrx group versus sham vr group p022 013 respectively pain catastrophizing pain selfefficacy pain acceptance prescription opioid use morphine milligram equivalent reach statistical significance either group use overthecounter analgesic use reduced easevrx plt01 sham vr conclusions easevrx high user satisfaction superior clinically meaningful symptom reduction average pain intensity painrelated interference activity mood stress compared sham vr additional research needed determine durability treatment effects characterize mechanisms treatment effects homebased vr may expand access effective ondemand nonpharmacologic treatment chronic low back pain trial registration clinicaltrialsgov nct04415177 httpsclinicaltrialsgovct2shownct04415177 international registered report identifier irrid rr210219625291