In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample
Objective: To determine whether an 8-week, self-administered in-home, behavioral skills virtual reality program for chronic low back pain (RelieVRx) that trains diaphragmatic breathing, biofeedback, cognition and emotion regulation, mindfulness, and pain education skills, is superior to a strong act...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | Mayo Clinic Proceedings: Digital Health |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949761223000834 |
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| author | Todd Maddox, PhD Liesl Oldstone, PhD Charisse Y. Sparks, MD Josh Sackman, MBA Alexis Oyao, BS Laura Garcia, PhD Roselani U. Maddox, BS Kelsey Ffrench, MS Heidy Garcia, JD Takisha Adair, MBA Ann Irvin, BS David Maislin, PhD Brendan Keenan, MS Robert Bonakdar, MD Beth D. Darnall, PhD |
| author_facet | Todd Maddox, PhD Liesl Oldstone, PhD Charisse Y. Sparks, MD Josh Sackman, MBA Alexis Oyao, BS Laura Garcia, PhD Roselani U. Maddox, BS Kelsey Ffrench, MS Heidy Garcia, JD Takisha Adair, MBA Ann Irvin, BS David Maislin, PhD Brendan Keenan, MS Robert Bonakdar, MD Beth D. Darnall, PhD |
| author_sort | Todd Maddox, PhD |
| collection | DOAJ |
| description | Objective: To determine whether an 8-week, self-administered in-home, behavioral skills virtual reality program for chronic low back pain (RelieVRx) that trains diaphragmatic breathing, biofeedback, cognition and emotion regulation, mindfulness, and pain education skills, is superior to a strong active Sham at day 56 for improving pain intensity and pain interference, in a large real-world sample. Patients and Methods: Participants included a national sample of demographically diverse individuals with self-reported nonmalignant chronic low back pain ≥3 months duration with an average pain intensity and pain interference of ≥4/10. Participants were randomized 1:1 to RelieVRx or active Sham, and data were collected from January 31, 2022, to October 31, 2022. We evaluated group differences in brief pain inventory, pain intensity, and pain interference to day 56 (end of treatment). Results: Of the 1067 participants (772 women, 293 men, and 2 others; mean ± SD age, 50.8±13.2 years) randomized (1:1) into 2 groups: RelieVRx (n=536) and Sham (n=531) comprised the modified intention-to-treat analytic dataset. RelieVRx was superior to Sham for pain intensity and pain interference reductions from pretreatment to day 56 (difference from Sham, pain intensity: 0.406 [0.170-0.642] and pain interference: 0.523 [0.285-0.760]). Pain intensity and interference reductions for RelieVRx at day 56 were clinically meaningful (pain intensity: 2.0 [out of 10] points [1.73-2.06], pain interference: 2.3 points [1.99-2.33]). Conclusion: An 8-week self-administered behavioral skills virtual reality program was found to impart clinically meaningful improvements above a strong active control comparison on pain intensity and pain interference in clinically severe and diverse adults with chronic low back pain. Trial Registration: clinicaltrials.gov Identifier: NCT05263037 |
| first_indexed | 2024-04-24T17:26:26Z |
| format | Article |
| id | doaj.art-e8e9d5aa3dd34f92acdf15ce7c10e5bb |
| institution | Directory Open Access Journal |
| issn | 2949-7612 |
| language | English |
| last_indexed | 2024-04-24T17:26:26Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Mayo Clinic Proceedings: Digital Health |
| spelling | doaj.art-e8e9d5aa3dd34f92acdf15ce7c10e5bb2024-03-28T06:40:53ZengElsevierMayo Clinic Proceedings: Digital Health2949-76122023-12-0114563573In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse SampleTodd Maddox, PhD0Liesl Oldstone, PhD1Charisse Y. Sparks, MD2Josh Sackman, MBA3Alexis Oyao, BS4Laura Garcia, PhD5Roselani U. Maddox, BS6Kelsey Ffrench, MS7Heidy Garcia, JD8Takisha Adair, MBA9Ann Irvin, BS10David Maislin, PhD11Brendan Keenan, MS12Robert Bonakdar, MD13Beth D. Darnall, PhD14AppliedVR, Inc., Van Nuys, CA; Correspondence: Address to Todd Maddox, PhD, 16760 Stagg Street, Suite 216. Van Nuys, CA 91406-1642.AppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CAFound Inc., San Francisco, CAAppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CAAppliedVR, Inc., Van Nuys, CABiomedical Statistical Consulting, Wynnewood, PABiomedical Statistical Consulting, Wynnewood, PAScripps Center for Integrative Medicine, La Jolla, CADepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, CAObjective: To determine whether an 8-week, self-administered in-home, behavioral skills virtual reality program for chronic low back pain (RelieVRx) that trains diaphragmatic breathing, biofeedback, cognition and emotion regulation, mindfulness, and pain education skills, is superior to a strong active Sham at day 56 for improving pain intensity and pain interference, in a large real-world sample. Patients and Methods: Participants included a national sample of demographically diverse individuals with self-reported nonmalignant chronic low back pain ≥3 months duration with an average pain intensity and pain interference of ≥4/10. Participants were randomized 1:1 to RelieVRx or active Sham, and data were collected from January 31, 2022, to October 31, 2022. We evaluated group differences in brief pain inventory, pain intensity, and pain interference to day 56 (end of treatment). Results: Of the 1067 participants (772 women, 293 men, and 2 others; mean ± SD age, 50.8±13.2 years) randomized (1:1) into 2 groups: RelieVRx (n=536) and Sham (n=531) comprised the modified intention-to-treat analytic dataset. RelieVRx was superior to Sham for pain intensity and pain interference reductions from pretreatment to day 56 (difference from Sham, pain intensity: 0.406 [0.170-0.642] and pain interference: 0.523 [0.285-0.760]). Pain intensity and interference reductions for RelieVRx at day 56 were clinically meaningful (pain intensity: 2.0 [out of 10] points [1.73-2.06], pain interference: 2.3 points [1.99-2.33]). Conclusion: An 8-week self-administered behavioral skills virtual reality program was found to impart clinically meaningful improvements above a strong active control comparison on pain intensity and pain interference in clinically severe and diverse adults with chronic low back pain. Trial Registration: clinicaltrials.gov Identifier: NCT05263037http://www.sciencedirect.com/science/article/pii/S2949761223000834behavioral healthchronic low back painvirtual reality |
| spellingShingle | Todd Maddox, PhD Liesl Oldstone, PhD Charisse Y. Sparks, MD Josh Sackman, MBA Alexis Oyao, BS Laura Garcia, PhD Roselani U. Maddox, BS Kelsey Ffrench, MS Heidy Garcia, JD Takisha Adair, MBA Ann Irvin, BS David Maislin, PhD Brendan Keenan, MS Robert Bonakdar, MD Beth D. Darnall, PhD In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample Mayo Clinic Proceedings: Digital Health behavioral health chronic low back pain virtual reality |
| title | In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample |
| title_full | In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample |
| title_fullStr | In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample |
| title_full_unstemmed | In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample |
| title_short | In-Home Virtual Reality Program for Chronic Lower Back Pain: A Randomized Sham-Controlled Effectiveness Trial in a Clinically Severe and Diverse Sample |
| title_sort | in home virtual reality program for chronic lower back pain a randomized sham controlled effectiveness trial in a clinically severe and diverse sample |
| topic | behavioral health chronic low back pain virtual reality |
| url | http://www.sciencedirect.com/science/article/pii/S2949761223000834 |
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