The short-term effects of head-mounted virtual-reality on neuropathic pain intensity in people with spinal cord injury pain: a randomised cross-over pilot study

Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.

In order to take advantage of the potential offered by the medium of virtual reality (VR), it will be essential to develop an understanding of how to maximize the desirable experience of “presence” in a virtual space (“being there”), and how to minimize the undesirable feeling of “cybersickness” (a constellation of discomfort symptoms experienced in VR). Although there have been frequent reports of a possible link between the observer’s sense of presence and the experience of bodily discomfort in VR, the amount of literature that discusses the nature of the relationship is limited. Recent research has underlined the possibility that these variables have shared causes, and that both factors may be manipulated with a single approach. This review paper summarizes the concepts of presence and cybersickness and highlights the strengths and gaps in our understanding about their relationship. We review studies that have measured the association between presence and cybersickness, and conclude that the balance of evidence favors a negative relationship between the two factors which is driven principally by sensory integration processes. We also discuss how system immersiveness might play a role in modulating both presence and cybersickness. However, we identify a serious absence of high-powered studies that aim to reveal the nature of this relationship. Based on this evidence we propose recommendations for future studies investigating presence, cybersickness, and other related factors.