In-home virtual reality program for chronic low back pain: durability of a randomized, placebo-controlled clinical trial to 18 months post-treatment

Maddox, Todd; Garcia, Heidy; Ffrench, Kelsey; Maddox, Roselani; García, Laura Martínez; Krishnamurthy, Parthasarathy; Okhotin, David; Sparks, C.; Oldstone, Liesl; Birckhead, Brandon; Sackman, Josh; Mackey, Ian; Louis, Robert G.; Salmasi, Vafi; Oyao, Alexis; Darnall, Beth D.

doi:10.1136/rapm-2022-104093

Cited by 13 publications

(15 citation statements)

References 4 publications

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“…Various randomized trials of virtual reality presentations in patients with chronic lumbar pain or fibromyalgia report high user satisfaction, reduced pain, and meaningful reductions in painrelated interference with activity, mood, sleep, and stress, [19][20][21] as well as durability of the treatment effect for several months. 10 However, evidence is less consistent for acute or postoperative pain treatment with virtual reality-based interventions. Another trial (N = 64) reported that hypnosis, which shares some characteristics of relaxing virtual reality, 5 reduces opioid use.…”

Section: Discussionmentioning

confidence: 99%

“…5,7,8 There is evidence of analgesia from virtual reality for chronic pain, possibly lasting for several months. 9,10 Evidence supporting virtual reality for postoperative analgesia remains scarce. A few randomized trials reported reduced pain after some procedures such as episiotomy, dressing change for hand injuries, and various types of wounds; furthermore, an observational study reports improvement of pain after cardiac surgery.…”

Section: Anesthesia and Analgesiamentioning

confidence: 99%

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Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial

Araujo-Duran,

Kopac,

Montalvo Campana

et al. 2023

Anesthesia &Amp; Analgesia

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BACKGROUND: Relaxation and distraction provided by virtual reality presentations might be analgesic and reduce the need for opioid analgesia. We tested the hypothesis that a virtual reality program (AppliedVR) decreases acute postoperative pain and opioid requirements in patients recovering from hip arthroplasty. We also evaluated whether virtual reality distraction improves patient mobility and reduces the need for antiemetics. METHODS: We evaluated 106 adults who were recovering from elective primary total hip arthroplasty. Participating patients were randomized to 2- to 8-minute-long 3-dimensional immersive virtual reality relaxation and distraction video presentations (eg, guided breathing exercises, games, mindfulness) or to 2-dimensional presentations of nature short films (eg, forest wildlife) with neutral music that was chosen to be neither overly relaxing nor distracting, presented through identical headsets. Our primary outcome was pain after virtual reality or sham video presentations, adjusted for pretreatment scores. Secondary outcomes included total opioid consumption, pain scores obtained per routine by nurse staff, perception of video system usability, and pain 1 week after hospital discharge. RESULTS: Fifty-two patients were randomized to virtual reality distraction and relaxation, and 54 were assigned to 2-dimensional sham presentations. Virtual reality presentations were not found to affect pain scores before and after presentations, with an estimated difference in means (virtual reality minus sham video) of −0.1 points (95% confidence interval [CI], −0.5 to 0.2; P = .391) on a 0 to 10 scale, with 10 being the worst. The mean (standard error [SE]) after-intervention pain score was estimated to be 3.4 (0.3) in the virtual reality group and 3.5 (0.2) in the reference group. Virtual reality treatment was not found to affect postoperative opioid consumption in morphine milligram equivalents, with an estimated ratio of geometric means (virtual reality/sham video) of 1.2 (95% CI, 0.6–2.1; P = .608). Virtual reality presentations were not found to reduce pain scores collected every 4 hours by nursing staff, with an estimated difference in means of 0.1 points (95% CI, −0.9 to 0.7; P = .768). CONCLUSIONS: We did not observe statistically significant or clinically meaningful reductions in average pain scores or opioid consumption. As used in our trial, virtual reality did not reduce acute postoperative pain.

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Section: Discussionmentioning

confidence: 99%

Section: Anesthesia and Analgesiamentioning

confidence: 99%

Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial

Araujo-Duran,

Kopac,

Montalvo Campana

et al. 2023

Anesthesia &Amp; Analgesia

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“…However, despite these issues, our sensitivity analysis still showed a significant effect across all clinically important outcomes in all retrieved studies; it is unlikely that this is due to chance alone. Furthermore, the analgesic effect of VR is not limited to CNNP, studies in chronic low back pain, 43 traumatic and nontraumatic pain in emergency patients, 44 and endometriosis-related pelvic pain 45 show significant pain modulation effects of VR. These reports suggest that the use of VR may be effective for other types of acute and chronic pain.…”

Section: Discussionmentioning

confidence: 99%

The Use of Virtual Reality in the Rehabilitation of Chronic Nonspecific Neck Pain

Ye,

Koh,

Jaiswal

et al. 2023

The Clinical Journal of Pain

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Objectives: There has been a major interest in using virtual reality (VR) as a pain-management tool. This systematic review evaluated the literature on the use of VR in the treatment of chronic nonspecific neck pain (CNNP). Methods: Electronic database searches were conducted in Cochrane, Medline, PubMed, Web of Science, Embase, and Scopus between inception and November 22, 2022. Search terms used were synonyms of “chronic neck pain” and “virtual reality.” Inclusion criteria were as follows: chronic neck pain patients or pain lasting longer than 3 months; nonspecific neck pain; adult population; VR intervention; and functional and/or psychological outcomes. Study characteristics, quality, participant demographics, and results were independently extracted by 2 reviewers. Results: VR interventions demonstrated significant improvement in patients experiencing CNNP. Scores in the visual analogue scale, the Neck Disability Index, and range of motion were significantly improved compared with baseline but not better than gold standard kinematic treatments. Discussion: Our results suggest that VR is a promising tool for chronic pain management; however, there is a lack of VR intervention design consistency, objective outcome measures, follow-up reporting, and large sample sizes. Future research should focus on designing VR interventions to serve specific, individualized movement goals as well as combining quantifiable outcomes with existing self-report measures.

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“…To evaluate the quality of life, the self-reported Patient's Global Impression of Change Scale was used. Follow-up data from the pivotal RCT were collected and reported after 3, 6, and 18 months [98,119,120]. RelieVRx was evaluated in CLBP patients in a 21-day pilot RCT [117], as well as in a 56-day, double-blind, placebo-controlled RCT [98,[117][118][119][120].…”

Section: Emergence Of Digital Therapeutics For Clbpmentioning

confidence: 99%

“…Follow-up data from the pivotal RCT were collected and reported after 3, 6, and 18 months [98,119,120]. RelieVRx was evaluated in CLBP patients in a 21-day pilot RCT [117], as well as in a 56-day, double-blind, placebo-controlled RCT [98,[117][118][119][120]. The pivotal efficacy and safety RCT of RelieVRx (registered as NCT00415177 in clinicaltrials.gov) included 179 CLBP patients assigned to either the eight-week treatment group using RelieVRx 3D immersive pain relief program, or to the control group (sham VR program displayed 2D nature content and did not provide skills training) [118].…”

Section: Emergence Of Digital Therapeutics For Clbpmentioning

confidence: 99%

Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health

Rohaj

Bułaj

2023

Healthcare

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Digital therapeutics (DTx, software as a medical device) provide personalized treatments for chronic diseases and expand precision medicine beyond pharmacogenomics-based pharmacotherapies. In this perspective article, we describe how DTx for chronic low back pain (CLBP) can be integrated with pharmaceutical drugs (e.g., NSAIDs, opioids), physical therapy (PT), cognitive behavioral therapy (CBT), and patient empowerment. An example of an FDA-authorized DTx for CLBP is RelieVRx, a prescription virtual reality (VR) app that reduces pain severity as an adjunct treatment for moderate to severe low back pain. RelieVRx is an immersive VR system that delivers at-home pain management modalities, including relaxation, self-awareness, pain distraction, guided breathing, and patient education. The mechanism of action of DTx is aligned with recommendations from the American College of Physicians to use non-pharmacological modalities as the first-line therapy for CLBP. Herein, we discuss how DTx can provide multimodal therapy options integrating conventional treatments with exposome-responsive, just-in-time adaptive interventions (JITAI). Given the flexibility of software-based therapies to accommodate diverse digital content, we also suggest that music-induced analgesia can increase the clinical effectiveness of digital interventions for chronic pain. DTx offers opportunities to simultaneously address the chronic pain crisis and opioid epidemic while supporting patients and healthcare providers to improve therapy outcomes.

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In-home virtual reality program for chronic low back pain: durability of a randomized, placebo-controlled clinical trial to 18 months post-treatment

Cited by 13 publications

References 4 publications

Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial

Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial

The Use of Virtual Reality in the Rehabilitation of Chronic Nonspecific Neck Pain

Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health

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