P-013 - (Poster #13) From Randomized Controlled Trial to Real World Evidence: Age-Invariant Benefits of In-Home Skills-Based Virtual Reality-Delivered Therapy for Chronic Lower Back Pain

Chronic low back pain (CLBP) impacts approximately one-third of adults globally, with the prevalence increasing with age.1 Pain education and cognitive behavior therapy (CBT) are recommended as first-line treatments given their low-risk, but barriers such as few trained and available local therapists, health insurance limits, and burdens associated with travel and treatment time impede their broad implementation. 2-7 Low-risk, accessible in-home solutions like virtual reality-delivered therapy provide therapeutic content in a consistent, quality-controlled manner and might address these shortcomings. However, questions remain about whether demographic factors, such as age, could impact patient engagement and treatment effectiveness.8-9  In a recent study, Maddox et al (2024)10 conducted a secondary analysis of a large-sample randomized controlled trial (RCT)11 and found that pain intensity and pain interference reductions and therapeutic program engagement at end-of-treatment for an FDA-authorized, in-home 8-week Skills-Based Virtual Reality Therapy for chronic lower back pain was generally unaffected by a number of sociodemographic factors including age (< 65 vs 65+). One notable exception was that older adults were significantly more engaged with the program than younger adults, although both groups were highly engaged.

Purpose/Objectives:

This research extended the age-based RCT secondary analysis in a number of ways. First, we expanded the analysis beyond the primary endpoints of pain intensity and interference to include the secondary endpoints of anxiety, sleep, depression, and physical disability. Second, we explored age-effects beyond end-of-treatment to 12-months post-treatment. Third, we conducted an exploratory analysis examining the interaction between age and high (HICP; BPI Interference ≥ 7) vs lower impact chronic pain (LICP; BPI Interference < 7)12-15 on clinical effectiveness. Our previous research showed larger pain intensity and interference reductions for HICP than LICP following Skills-Based VR therapy16. Finally, we examined the effect of age on therapeutic program engagement in the 2000+ patients who have received a prescription for the FDA-authorized Skills-Based Virtual Reality Therapy from a healthcare professional. This real-world sample (independent of the RCT) provides critical insights into the use of the VR-delivered therapy in the wild.

Methods: A national sample of N=1093 individuals with self-reported non-malignant low back pain > 3 months duration and with average pain intensity and pain interference > 4/10 were enrolled and randomized 1:1 to one of two 56-session VR-delivered programs: (1) Skills-Based VR (immersive pain relief skills); or (2) Sham VR (two-dimensional (2D) nature content). The fixed-sequence Skills-Based VR-delivered program is an immersive multimodal pain self-management program that incorporates evidence-based principles of CBT, mindfulness, and pain neuroscience education. Consistent with VR-CORE trial guidelines, an active control using non-immersive 2D content within a VR headset was selected as the most rigorous VR placebo.17 Relevant validated instruments were the Brief Pain Inventory, PROMIS Anxiety, PROMIS Sleep Disturbance, PROMIS Depression, and Oswestry Disability Index (ODI), all collected pre-treatment, immediately following treatment, and at 12-months post-treatment. Therapeutic program engagement was collected at end-of-treatment following return of the VR device and download of the data. To examine age effects for 65+ vs < 65 participants from baseline to end-of-treatment and 12-months post treatment, Mixed Models for Repeated Measures (MMRM) as well as General Linear Model (GLM) analyses were conducted.

Results:

Maddox et al11 conducted an RCT in N=1093 adults with cLBP. Clinically meaningful reductions in pain intensity (2.0) and interference (2.3) emerged for the Skills-Based VR program that were significantly larger than for Sham. Pain reductions remained at 12-months post-treatment although attenuated (pain intensity reduction = 1.7, pain interference reduction = 1.918). Therapeutic program engagement was high (4.7 therapeutic episodes/week). The large sample in Maddox et al11 allowed us to conduct secondary analyses examining the impact of age (65+ vs < 65) on clinical effectiveness and therapeutic program engagement for Skills-Based VR. MMRM yielded a non-significant age group x time interaction for BPI Pain Intensity and Interference (ps > .60). Pain intensity and interference reductions from baseline to end-of-treatment and 12-months post-treatment did not differ across age (ps > .25), but for both age groups and time points the reductions were statistically significant (ps < .001). MMRM yielded a non-significant age group x time interaction for PROMIS Sleep and PROMIS Depression (ps > .50). Sleep and depression reductions from baseline to end-of-treatment and 12-months post-treatment did not differ across age (ps > .15), but for both age groups and time points the reductions were statistically significant (ps < .02). MMRM yielded a non-significant age group x time interaction for PROMIS Anxiety (p > .25), but the anxiety reductions from baseline to end-of-treatment and 12-months post-treatment were larger and statistically significant for 65+ (ps < .025) but not < 65 participants. MMRM yielded a significant age group x time interaction for the ODI (p < .05), with larger reductions in disability for < 65 participants at both end-of-treatment and 12-months post-treatment (ps < .001). In line with our previous research we found larger pain intensity and interference reductions for HICP than LICP patients for both age groups. 

Finally, our real world evidence from 2000+ patients who received a prescription from a healthcare professional and have completed the Skills-Based VR therapy showed that older adults were significantly more engaged with the program than younger adults (therapeutic episodes/week: older = 4.8, younger = 4.3; p < .05), although both groups were highly engaged.

Conclusions/Implications for future research and/or clinical care: In a large-scale RCT, we found that age does not affect treatment effectiveness for the Skills-Based VR Therapy with both age groups obtaining meaningful reductions in pain intensity and pain interference that are robust to 12-months post-treatment. The same held for reductions in sleep disturbance and depression. Interestingly, older adults showed significant reductions in anxiety at both time points whereas younger adults did not. On the other hand, younger adults showed larger reductions in physical disability at both time points than younger adults. HICP participants showed greater pain intensity and pain interference reductions than LICP participants at both time points, and this effect was invariant across age groups. In our real-world sample of 2000+ patients who received a prescription for and completed the VR-delivered therapy, older adults completed more therapeutic episodes per week than younger adults, although engagement was strong for both groups. Taken together, these findings suggest that age does not negatively impact clinical effectiveness, durability of clinical effectiveness or therapeutic engagement, and suggests that the Skills-Based VR Therapy offers a powerful tool for mitigating chronic lower back pain that is self-administered in-home, requires no Wi-Fi connectivity, uses gaze-based navigation, and requires on average 6 min/day.