Double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain (during COVID-19).
Identifieur interne : 000081 ( Main/Exploration ); précédent : 000080; suivant : 000082Double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain (during COVID-19).
Auteurs : Beth Darnall [États-Unis] ; Laura Garcia [États-Unis] ; Brandon Birckhead [États-Unis] ; Parthasarathy Krishnamurthy [États-Unis] ; Ian Mackey [États-Unis] ; Josh Sackman [États-Unis] ; Robert Louis [États-Unis] ; Todd Maddox [États-Unis]Source :
- Journal of medical Internet research [ 1438-8871 ] ; 2021.
Abstract
BACKGROUND
Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain.
OBJECTIVE
Objective: To conduct a double-blind, parallel arm, single cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic.
METHODS
Methods: A national online convenience sample of individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework.
RESULTS
The study sample was 179 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx vs. Sham VR (p<0.0001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest p-value = .0090), and between-groups Cohen's d effect sizes ranged from 0.40 to 0.49 indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17-1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between group comparisons for physical function and sleep disturbance showed superiority for the EaseVRx group vs. the Sham VR group (p=0.0224 and p=.0132, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p<0.01) but not for ShamVR.
CONCLUSIONS
EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand non-pharmacologic treatment for chronic low back pain.
CLINICALTRIAL
ClinicalTrials.gov, NCT04415177.
INTERNATIONAL REGISTERED REPORT
RR2-25291.
DOI: 10.2196/26292
PubMed: 33484240
Affiliations:
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Bauer College of Business, University of Houston, Houston, US.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>C.T. Bauer College of Business, University of Houston, Houston</wicri:regionArea><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Mackey, Ian" sort="Mackey, Ian" uniqKey="Mackey I" first="Ian" last="Mackey">Ian Mackey</name><affiliation wicri:level="3"><nlm:affiliation>AppliedVR, Inc., Los Angeles, US.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AppliedVR, Inc., Los Angeles</wicri:regionArea><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Sackman, Josh" sort="Sackman, Josh" uniqKey="Sackman J" first="Josh" last="Sackman">Josh Sackman</name><affiliation wicri:level="3"><nlm:affiliation>AppliedVR, Inc., Los Angeles, US.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AppliedVR, Inc., Los Angeles</wicri:regionArea><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Louis, Robert" sort="Louis, Robert" uniqKey="Louis R" first="Robert" last="Louis">Robert Louis</name><affiliation wicri:level="1"><nlm:affiliation>Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach, US.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach</wicri:regionArea><wicri:noRegion>Newport Beach</wicri:noRegion></affiliation></author><author><name sortKey="Maddox, Todd" sort="Maddox, Todd" uniqKey="Maddox T" first="Todd" last="Maddox">Todd Maddox</name><affiliation wicri:level="3"><nlm:affiliation>AppliedVR, Inc., Los Angeles, US.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>AppliedVR, Inc., Los Angeles</wicri:regionArea><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j">Journal of medical Internet research</title><idno type="eISSN">1438-8871</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain.</p></div><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>Objective: To conduct a double-blind, parallel arm, single cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Methods: A national online convenience sample of individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>The study sample was 179 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx vs. Sham VR (p<0.0001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest p-value = .0090), and between-groups Cohen's d effect sizes ranged from 0.40 to 0.49 indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17-1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between group comparisons for physical function and sleep disturbance showed superiority for the EaseVRx group vs. the Sham VR group (p=0.0224 and p=.0132, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p<0.01) but not for ShamVR.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand non-pharmacologic treatment for chronic low back pain.</p></div><div type="abstract" xml:lang="en"><p><b>CLINICALTRIAL</b></p><p>ClinicalTrials.gov, NCT04415177.</p></div><div type="abstract" xml:lang="en"><p><b>INTERNATIONAL REGISTERED REPORT</b></p><p>RR2-25291.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33484240</PMID><DateRevised><Year>2021</Year><Month>01</Month><Day>23</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1438-8871</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2021</Year><Month>Jan</Month><Day>13</Day></PubDate></JournalIssue><Title>Journal of medical Internet research</Title><ISOAbbreviation>J Med Internet Res</ISOAbbreviation></Journal><ArticleTitle>Double-blind, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain (during COVID-19).</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.2196/26292</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Objective: To conduct a double-blind, parallel arm, single cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Methods: A national online convenience sample of individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between-within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The study sample was 179 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx vs. Sham VR (p<0.0001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest p-value = .0090), and between-groups Cohen's d effect sizes ranged from 0.40 to 0.49 indicating superiority was moderately clinically meaningful. For EaseVRx, large pre-post effect sizes ranged from 1.17-1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between group comparisons for physical function and sleep disturbance showed superiority for the EaseVRx group vs. the Sham VR group (p=0.0224 and p=.0132, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p<0.01) but not for ShamVR.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand non-pharmacologic treatment for chronic low back pain.</AbstractText><AbstractText Label="CLINICALTRIAL" NlmCategory="UNASSIGNED">ClinicalTrials.gov, NCT04415177.</AbstractText><AbstractText Label="INTERNATIONAL REGISTERED REPORT" NlmCategory="UNASSIGNED">RR2-25291.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Darnall</LastName><ForeName>Beth</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Stanford University School of Medicine, 1070 Arastradero RoadSte 200, MC5596, Palo Alto, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garcia</LastName><ForeName>Laura</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>AppliedVR, Inc., Los Angeles, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Birckhead</LastName><ForeName>Brandon</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>AppliedVR, Inc., Los Angeles, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Krishnamurthy</LastName><ForeName>Parthasarathy</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>C.T. Bauer College of Business, University of Houston, Houston, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mackey</LastName><ForeName>Ian</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>AppliedVR, Inc., Los Angeles, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sackman</LastName><ForeName>Josh</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>AppliedVR, Inc., Los Angeles, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Louis</LastName><ForeName>Robert</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Pickup Family Neurosciences Institute, Hoag Memorial Hospital, Newport Beach, US.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maddox</LastName><ForeName>Todd</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>AppliedVR, Inc., Los Angeles, US.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04415177</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>01</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>Canada</Country><MedlineTA>J Med Internet Res</MedlineTA><NlmUniqueID>100959882</NlmUniqueID><ISSNLinking>1438-8871</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>1</Month><Day>23</Day><Hour>12</Hour><Minute>5</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>1</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>1</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33484240</ArticleId><ArticleId IdType="doi">10.2196/26292</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li><li>Texas</li></region><settlement><li>Houston</li><li>Los Angeles</li><li>Palo Alto</li></settlement></list><tree><country name="États-Unis"><region name="Californie"><name sortKey="Darnall, Beth" sort="Darnall, Beth" uniqKey="Darnall B" first="Beth" last="Darnall">Beth Darnall</name></region><name sortKey="Birckhead, Brandon" sort="Birckhead, Brandon" uniqKey="Birckhead B" first="Brandon" last="Birckhead">Brandon Birckhead</name><name sortKey="Garcia, Laura" sort="Garcia, Laura" uniqKey="Garcia L" first="Laura" last="Garcia">Laura Garcia</name><name sortKey="Krishnamurthy, Parthasarathy" sort="Krishnamurthy, Parthasarathy" uniqKey="Krishnamurthy P" first="Parthasarathy" last="Krishnamurthy">Parthasarathy Krishnamurthy</name><name sortKey="Louis, Robert" sort="Louis, Robert" uniqKey="Louis R" first="Robert" last="Louis">Robert Louis</name><name sortKey="Mackey, Ian" sort="Mackey, Ian" uniqKey="Mackey I" first="Ian" last="Mackey">Ian Mackey</name><name sortKey="Maddox, Todd" sort="Maddox, Todd" uniqKey="Maddox T" first="Todd" last="Maddox">Todd Maddox</name><name sortKey="Sackman, Josh" sort="Sackman, Josh" uniqKey="Sackman J" first="Josh" last="Sackman">Josh Sackman</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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