The FDA clears AppliedVR headset to help treat fibromyalgia and chronic pain

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FDA Des­ig­nates First Vir­tu­al Real­i­ty Device for Chron­ic Pain (Pain News Network):

Applied­VR, a Los Ange­les-based vir­tu­al real­i­ty com­pa­ny, has announced that its EaseVRx head­set has received Break­through Device Des­ig­na­tion from the Food and Drug Admin­is­tra­tion for treat­ing fibromyal­gia and chron­ic intractable low back pain.

EaseVRx is the first vir­tu­al real­i­ty (VR) device to get a Break­through Des­ig­na­tion from the FDA for treat­ing a chron­ic pain con­di­tion. The des­ig­na­tion speeds up the devel­op­ment and review of new med­ical devices that treat life-threat­en­ing or irre­versibly debil­i­tat­ing dis­eases or con­di­tions. It could also speed up insur­ance cov­er­age of VR ther­a­py for chron­ic pain … “Vir­tu­al real­i­ty is a promis­ing skills-based behav­ioral med­i­cine that has been shown to have high patient engage­ment and sat­is­fac­tion,” said Beth Dar­nall, PhD, AppliedVR’s chief sci­ence advi­sor. “How­ev­er, chron­ic pain patients to date have had very lim­it­ed access to it, so we’re excit­ed to con­tin­ue work­ing with the FDA to devel­op our plat­form and get it into the mar­ket faster.”

Recent study:

Self-Admin­is­tered Skills-Based Vir­tu­al Real­i­ty Inter­ven­tion for Chron­ic Pain: Ran­dom­ized Con­trolled Pilot Study (JMIR For­ma­tive Research). From the abstract:

  • Back­ground: Patients with chron­ic pain often have lim­it­ed access to com­pre­hen­sive care that includes behav­ioral pain man­age­ment strate­gies. Vir­tu­al real­i­ty (VR) is an immer­sive tech­nol­o­gy and emerg­ing dig­i­tal behav­ioral pain ther­a­py with anal­gesic effi­ca­cy for acute pain. We found no sci­en­tif­ic lit­er­a­ture on skills-based VR behav­ioral pro­grams for chron­ic pain populations.
  • Objec­tive: The pri­ma­ry aim of this study is to eval­u­ate the fea­si­bil­i­ty of a self-admin­is­tered VR pro­gram that includ­ed con­tent and skills informed by evi­dence-based behav­ioral treat­ment for chron­ic pain. The sec­ondary aim is to deter­mine the pre­lim­i­nary effi­ca­cy of the VR pro­gram in terms of aver­age pain inten­si­ty and pain-relat­ed inter­fer­ence with activ­i­ty, stress, mood, and sleep, and its impact on pain-relat­ed cog­ni­tion and self-effi­ca­cy. The ter­tiary aim was to con­duct a ran­dom­ized con­trolled tri­al (RCT) and com­pare the VR treat­ment with an audio-only treat­ment. This com­par­i­son iso­lat­ed the immer­sive effects of the VR pro­gram, there­by inform­ing poten­tial mech­a­nisms of effect.
  • Con­clu­sions: High engage­ment and sat­is­fac­tion com­bined with low lev­els of adverse effects sup­port the fea­si­bil­i­ty and accept­abil­i­ty of at-home skills-based VR for chron­ic pain. A sig­nif­i­cant reduc­tion in pain out­comes over the course of the 21-day treat­ment both with­in the VR group and com­pared with an audio-only ver­sion sug­gests that VR has the poten­tial to pro­vide enhanced treat­ment and greater improve­ment across a range of pain out­comes. These find­ings pro­vide a foun­da­tion for future research on VR behav­ioral inter­ven­tions for chron­ic pain.

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