scholarly journals An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19

10.2196/26292 ◽  
2021 ◽  
Vol 23 (2) ◽  
pp. e26292
Author(s):  
Laura M Garcia ◽  
Brandon J Birckhead ◽  
Parthasarathy Krishnamurthy ◽  
Josh Sackman ◽  
Ian G Mackey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
User Satisfaction ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Low Back ◽  
Average Pain Intensity ◽  
Average Pain

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 We aimed 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 A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 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: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen 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 to 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 versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. 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 nonpharmacologic treatment for chronic low back pain. Trial Registration ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID) RR2-10.2196/25291

scholarly journals Double-blind, pragmatic, 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) (Preprint)

2020 ◽  
Author(s):  
Beth Darnall ◽  
Laura Garcia ◽  
Brandon Birckhead ◽  
Parthasarathy Krishnamurthy ◽  
Ian Mackey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
User Satisfaction ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Low Back ◽  
Average Pain Intensity ◽  
Average Pain

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 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 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 56-day VR programs: (1) EaseVRx (pain relief skills immersive 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 change in average pain intensity and pain-related interference with activity, stress, mood, and sleep (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). Both groups improved significantly for all five primary outcomes; EaseVRx was superior to Sham VR for all primary outcomes except pain-related sleep interference. For EaseVRx, large pre-post effect sizes ranged from 1.06-1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. A greater proportion of participants in the EaseVRx group achieved > 30% reduction in pain intensity (EaseVRx: 65.5%; Sham VR: 40.5%), and 46% of EaseVRx achieved >50% reduction in pain. Physical function and sleep disturbance significantly improved for both treatment groups with superior improvements found for EaseVRx (p=0.0019 and p=.0353, respectively). Pain catastrophizing, pain self-efficacy, 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 Sham VR. 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 https://clinicaltrials.gov/ct2/show/NCT04415177 INTERNATIONAL REGISTERED REPORT RR2-25291

scholarly journals Comparative Associations of Working Memory and Pain Catastrophizing With Chronic Low Back Pain Intensity

2016 ◽  
Vol 96 (7) ◽  
pp. 1049-1056 ◽  
Author(s):  
Corey B. Simon ◽  
Trevor A. Lentz ◽  
Mark D. Bishop ◽  
Joseph L. Riley ◽  
Roger B. Fillingim ◽  
...  
Keyword(s):  
Working Memory ◽  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
Pain Catastrophizing ◽  
Future Research ◽  
Low Back ◽  
Cross Sectional ◽  
Daily Pain

Abstract Background Because of its high global burden, determining biopsychosocial influences of chronic low back pain (CLBP) is a research priority. Psychological factors such as pain catastrophizing are well established. However, cognitive factors such as working memory warrant further investigation to be clinically useful. Objective The purpose of this study was to determine how working memory and pain catastrophizing are associated with CLBP measures of daily pain intensity and movement-evoked pain intensity. Design This study was a cross-sectional analysis of individuals with ≥3 months of CLBP (n=60) compared with pain-free controls (n=30). Method Participants completed measures of working memory, pain catastrophizing, and daily pain intensity. Movement-evoked pain intensity was assessed using the Back Performance Scale. Outcome measures were compared between individuals with CLBP and those who were pain-free using nonparametric testing. Associations were determined using multivariate regression analyses. Results Participants with CLBP (mean age=47.7 years, 68% female) had lower working memory performance (P=.008) and higher pain catastrophizing (P&lt;.001) compared with pain-free controls (mean age=47.6 years, 63% female). For individuals with CLBP, only working memory remained associated with daily pain intensity (R2=.07, standardized beta=−.308, P=.041) and movement-evoked pain intensity (R2=.14, standardized beta=−.502, P=.001) after accounting for age, sex, education, and interactions between pain catastrophizing and working memory. Limitations The cross-sectional design prevented prospective analysis. Findings also are not indicative of overall working memory (eg, spatial) or cognitive performance. Conclusion Working memory demonstrated the strongest association with daily pain and movement-evoked pain intensity compared with (and after accounting for) established CLBP factors. Future research will elucidate the prognostic value of working memory on prevention and recovery of CLBP.

scholarly journals Rumination-Focused Cognitive-Behavioral Therapy for Chronic Low Back Pain: A Randomized Controlled Trial

2020 ◽  
Vol 9 ◽  
Author(s):  
Ali Soleymani ◽  
Abbas Masjedi Arani ◽  
Seyed Ahmad Raeissadat ◽  
Mohammad Hassan Davazdahemami
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Chronic Low Back Pain ◽  
Pain Catastrophizing ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Low Back ◽  
Randomized Controlled

Background: Chronic pain remains or reappears for more than 3 to 6 months, and it is influencing 20% of the global population. The pain catastrophizing affects pain intensity and psychological conditions of patients with chronic pain. Rumination-focused cognitive-behavioral therapy (RFCBT) targets rumination as the key component of pain catastrophizing. The aim of this study was to determine the effectiveness of RFCBT on depression, anxiety, and pain severity of individuals with chronic low back pain (LBP). Materials and Methods: In a randomized controlled trial, 30 patients aged between 20-55 years with diagnosed chronic LBP were chosen by convenience sampling and randomly allocated into intervention and control groups. All patients used their prescribed medications for pain management, but the intervention group received 12 weekly sessions of RFCBT, which was manualized psychotherapy to change unconstructive rumination to constructive rumination. Depression Anxiety and Stress scale-21 and chronic pain grade questionnaire were administered as pre-tests and re-administered after 3 and 6 months as post-test and follow-up assessments, respectively. Results: RFCBT significantly reduced depression (F1=23.01, P=0.001), anxiety (F1=25.7, P=0.001) and pain severity (F1=7.17, P=0.012) in patients with chronic LBP. Conclusion: RFCBT may offer benefits for treating patients with chronic low back pain when added to their usual pharmacological treatment. This benefit may be the result of targeting rumination as the key element of pain catastrophizing. [GMJ.2020;9:e1722]

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