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

García, Laura Martínez; Birckhead, Brandon; Krishnamurthy, Parthasarathy; Mackey, Ian; Sackman, Josh; Salmasi, Vafi; Louis, Robert G.; Maddox, Todd; Darnall, Beth D.

doi:10.1016/j.jpain.2021.12.002

Cited by 23 publications

(26 citation statements)

References 28 publications

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“…Finally, at the end of the study roughly 73% of the sample correctly guessed their treatment group assignment, suggesting that, despite extensive efforts to maintain face validity of sham VR and following published guidance [ 8 ], the actual blinding failed. Despite this, we previously reported equivalent treatment engagement between both groups and symptom benefits gained by sham VR participants [ 7 ], albeit sham VR was substantially less efficacious than therapeutic VR. Nevertheless, equivalent engagement in sham VR suggests acceptable control in terms of time and attention, exposure to treatment, device use, survey completion, and participant compensation.…”

Section: Discussionmentioning

confidence: 94%

“…This study extended the results of this same study sample (N=188) [ 4 , 7 ] to 6 months posttreatment to evaluate further the durability of VR treatment. This study also included outcomes for participant blinding and treatment group unmasking at 6 months posttreatment.…”

Section: Introductionmentioning

confidence: 81%

“…Demographic variables included age, gender, education level, race, ethnicity, employment status, annual household income, relationship status, back pain duration, state of residence, and zip code. The baseline survey included other measures of secondary outcomes that were omitted from our prior publication [ 7 ] and this report because we found no significant between-group changes for these measures at end-of-treatment when treatment effects are most pronounced (items from the Pain Catastrophizing Scale [ 9 ], 2-item Pain Self-Efficacy Questionnaire [ 10 ], and 8-item Chronic Pain Acceptance Questionnaire [ 11 ], and self-reported prescription opioid and over-the-counter analgesic medication use).…”

Section: Methodsmentioning

confidence: 99%

“…On comparing the groups, a greater proportion of participants in the EaseVRx group achieved ≥30% reduction in pain intensity, and 46% of EaseVRx participants achieved ≥50% reduction in pain [ 4 ]. At 3 months, EaseVRx showed significant superiority over sham VR for reducing pain intensity and pain-related interference (activity, stress, and sleep [new finding]), with moderate to large effect sizes (0.56-0.88) exceeding the thresholds for clinical meaningfulness [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

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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

García¹,

Birckhead²,

Krishnamurthy³

et al. 2022

J Med Internet Res

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Background We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding). Objective This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR. Methods E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function. Results Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness. Conclusions Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples. Trial Registration ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID) RR2-10.2196/25291

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 81%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

García¹,

Birckhead²,

Krishnamurthy³

et al. 2022

J Med Internet Res

Self Cite

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“…Although drug+digital combination therapies offer a full integration of pharmacotherapy and non-pharmacological intervention, to the best of our knowledge there are no currently known such drug-device combination products. Other future prospects for improved patient-centered pain management may include integration of drug-based analgesia with patient education delivered via digital health technologies ( 29 , 90 , 91 ), and integration of digital health technologies with self-care and therapeutic home environment ( 92 ).…”

Section: Discussionmentioning

confidence: 99%

Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care

Giravi

Biskupiak

Tyler

et al. 2022

Front. Digit. Health

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Digital therapeutics (DTx, mobile medical apps, software as a medical device) are rapidly emerging as clinically effective treatments for diverse chronic diseases. For example, the Food and Drug Administration (FDA) has recently authorized a prescription virtual reality (VR) app for treatment of moderate to severe low back pain. The FDA has also approved an adjunct digital therapy in conjunction with buprenorphine for opioid use disorder, further illustrating opportunities to integrate digital therapeutics with pharmacotherapies. There are ongoing needs to disseminate knowledge about advances in digital interventions among health care professionals, policymakers, and the public at large. This mini-review summarizes accumulating clinical evidence of digital interventions delivered via virtual reality and mobile apps to improve opioid-based analgesia. We identified relevant randomized controlled trials (RCTs) using Embase and PubMed databases which reported pain scores with a validated pain scale (e.g., visual analog scales, graphic rating scale, numeric rating scale) and use of a digital intervention in conjunction with opiates. Among identified RCTs, the majority of studies reported improved pain scores in the digital intervention group, as compared to “treatment as usual” group. Our work suggests that VR and mobile apps can be used as adjunct digital therapies for pain management. We discuss these findings in the context of how digital health technologies can transform patient-centered pharmacy care.

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Virtual Reality for Pain Management During High‐Resolution Manometry: A Randomized Clinical Trial

Palte,

Stewart,

Rives

et al. 2023

The Laryngoscope

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ObjectiveHigh‐resolution esophageal manometry (HRM) is the gold standard for the diagnosis of esophageal motility disorders. HRM is typically performed in the office with local anesthesia only, and many patients find it unpleasant and painful. The aim of this study was to examine the effects of the use of a virtual reality (VR) headset on pain and anxiety outcomes in patients with dysphagia undergoing HRM.MethodsPatients with dysphagia were prospectively recruited and randomized to undergo HRM with and without VR distraction. Data collected included the State‐Trait Anxiety Inventory‐6 (STAI‐6), the Short‐Form McGill Pain Questionnaire, heart rate, and galvanic skin response (GSR) tracings.ResultsForty subjects completed the study, including 20 subjects in the intervention arm and 20 in the control arm. There was evidence of a significant positive effect of VR on calmness (p = 0.0095) STAI‐6 rating, as well as on physiologic measures of pain with significantly decreased GSR rise time (p = 0.0137) and average rate of change of conductance change (p = 0.0035).ConclusionThe use of VR during HRM catheter insertion increased calmness compared to control. Change of skin conductance was also reduced in the VR group, suggesting decreased physiologic pain. This study supports the consideration of the use of VR as a distraction tool to improve patient comfort during HRM.Level of Evidence2 Laryngoscope, 2023

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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

Abstract: 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,

Cited by 23 publications

References 28 publications

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

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

Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care

Virtual Reality for Pain Management During High‐Resolution Manometry: A Randomized Clinical Trial

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