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.
behavioral health
chronic low back pain
treatment
virtual reality
Journal
Journal of medical Internet research
ISSN: 1438-8871
Titre abrégé: J Med Internet Res
Pays: Canada
ID NLM: 100959882
Informations de publication
Date de publication:
25 05 2022
25 05 2022
Historique:
received:
22
02
2022
accepted:
26
04
2022
revised:
22
03
2022
entrez:
25
5
2022
pubmed:
26
5
2022
medline:
28
5
2022
Statut:
epublish
Résumé
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). 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. 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. 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 (d 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. ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177. RR2-10.2196/25291.
Sections du résumé
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 (d
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.
Identifiants
pubmed: 35612905
pii: v24i5e37480
doi: 10.2196/37480
pmc: PMC9177046
doi:
Banques de données
ClinicalTrials.gov
['NCT04415177']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e37480Commentaires et corrections
Type : ErratumIn
Informations de copyright
©Laura Garcia, Brandon Birckhead, Parthasarathy Krishnamurthy, Ian Mackey, Josh Sackman, Vafi Salmasi, Robert Louis, Carina Castro, Roselani Maddox, Todd Maddox, Beth D Darnall. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 25.05.2022.
Références
J Pain. 2015 Feb;16(2):153-63
pubmed: 25463701
Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:191-211
pubmed: 30216744
Arthritis Res Ther. 2011;13(5):R147
pubmed: 21914216
Pain. 2016 Dec;157(12):2766-2772
pubmed: 27755279
J Pain Res. 2019 Jul 03;12:2053-2085
pubmed: 31308733
J Pain. 2022 May;23(5):822-840
pubmed: 34902548
Behav Sleep Med. 2011 Dec 28;10(1):6-24
pubmed: 22250775
Pain Med. 2015 Nov;16(11):2152-61
pubmed: 26257151
J Appl Meas. 2010;11(3):304-14
pubmed: 20847477
Multivariate Behav Res. 2019 Jan-Feb;54(1):85-99
pubmed: 30235003
JMIR Form Res. 2020 Jul 7;4(7):e17293
pubmed: 32374272
Front Psychol. 2013 Nov 26;4:863
pubmed: 24324449
Pain. 2009 Dec;146(3):238-244
pubmed: 19836888
J Med Internet Res. 2021 Feb 22;23(2):e26292
pubmed: 33484240
Pain. 2010 Jun;149(3):435-443
pubmed: 20188472
PLoS One. 2019 Aug 14;14(8):e0219115
pubmed: 31412029
Front Psychol. 2018 Dec 20;9:2508
pubmed: 30618938
JMIR Res Protoc. 2021 Feb 12;10(2):e27652
pubmed: 33577465
Int J Environ Res Public Health. 2021 Nov 11;18(22):
pubmed: 34831562
JMIR Ment Health. 2019 Jan 31;6(1):e11973
pubmed: 30702436
Pain Pract. 2020 Jul;20(6):656-675
pubmed: 32196892
PLoS One. 2017 May 30;12(5):e0178071
pubmed: 28557991