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Body movement as a biomarker for use in chronic pain rehabilitation: An embedded analysis of an RCT of a virtual reality solution for adults with chronic pain

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Sammeli Liikkanen, Mika Mäkinen, Teppo Huttunen, Toni Sarapohja, Carina Stenfors, Christopher Eccleston

Pain cannot be seen directly, but the way a person moves may leave a useful trace. This study asks whether moving faster during virtual-reality rehabilitation can signal that chronic back pain is improving.

Abstract

Introduction: Chronic low back pain (CLBP) is a major public health problem. Reliably measuring the effects of chronic pain on movement and activity, and any changes due to treatment, is a healthcare challenge. A recently published paper demonstrated that a novel digital therapeutic (DTxP) was efficacious in reducing fear of movement and increasing the quality of life of adult patients with moderate to severe CLBP. In this paper, we report a study of how data from wearable devices collected in this study could be used as a digital measure for use in studies of chronic low back pain. Methods: Movement, electrodermal recording, general activity and clinical assessment data were collected in a clinical trial of a novel digital therapeutic intervention (DTxP) by using the sensors in commercial Garmin Vivosmart 4, Empatica Embrace2 and Oculus Quest wearables. Wearable data were collected during and between the study interventions (frequent treatment sessions of DTxP). Data were analyzed using exploratory statistical analysis. Results: A pattern of increased longitudinal velocity in the movement data collected with right-hand, left-hand, and head sensors was observed in the study population. Correlations were observed with the changes in clinical scales (Tampa Scale of Kinesiophobia, EQ5D Overall health VAS, and EQ5D QoL score). The strongest correlation was observed with the increased velocity of head and right-hand sensors (Spearman correlation with increasing head sensor velocity and Tampa Scale of Kinesiophobia −0.45, Overall health VAS +0.67 and EQ5D QoL score −0.66). The sample size limited interpretation of electrodermal and general activity data. Discussion/Conclusion: We found a novel digital signal for use in monitoring the efficacy of a digital therapeutics (DTxP) in adults with CLBP. We discuss the potential use of such movement based digital markers as surrogate or additional endpoints in studies of chronic musculoskeletal pain.

Transcript

Pain cannot be seen directly, but the way a person moves may leave a useful trace. This study asks whether moving faster during virtual-reality rehabilitation can signal that chronic back pain is improving. Measuring pain and its harmful effects on many parts of life is a clinical and research challenge.

Pain is a private experience that cannot be observed except by the person who feels it. There is no objective measure of a subjective experience, but related changes can be measured through the body, observation, or changes in the movement of the body or limbs.

The study used a remote clinical trial of a virtual-reality treatment for adults with chronic low back pain, disability, and fear of movement and reinjury. The treatment reduced fear of movement and improved reported quality of life compared with the comparison treatments.

Adults experienced about thirty daily treatment sessions. Like watching someone become less cautious over repeated practice, that repeated exposure created an opportunity to explore movement data collected by the virtual-reality devices and two wearable devices. The goal was to identify movement behaviors that matched clinical data and consider whether they could be used as digital measures of treatment progress.

The study did not begin with a prediction about which movement would matter. Instead, it used the collected data to look for the movement patterns that emerged as important. The virtual-reality controllers recorded the positions of the hands over time.

Those recorded points were grouped into movement segments. The positions were then changed into speed in three dimensions, with speed at each moment calculated from the change since the previous moment. Across most people, left-hand movement became faster over the thirty study days, suggesting that participants may have moved better with practice or recovery.

But one person had only ten days of measurements, making that apparent improvement unusually steep and potentially misleading. The increase in movement speed was linked with a negative change in fear of movement and quality-of-life scores, and with a positive change in the overall health score.

Together, this indicates that increased movement speed was linked with improving clinical measures. When all the data were included, the links between movement and clinical results became weaker, although the head device still showed moderate links with the clinical measurements.

Movement data came from adults with chronic low back pain, disability, and fear of pain and reinjury who completed at least thirty virtual-reality rehabilitation sessions. It was possible to manage large datasets collected from multiple sources across people and over time.

But not every body signal was useful. Skin-response data were noisy and unstable between sessions, while heart-rate data lacked enough precision for meaningful clinical analysis. Changes in bodily movement over time appear to offer a clinically meaningful digital measure for rehabilitation studies involving adults with chronic low back pain.

More studies are needed, especially with more diverse participants and a wider range of clinical outcomes, before confidence in this approach can grow. Over time, faster movement was linked with better clinical measures, suggesting that body movement could help track recovery when pain itself cannot be measured directly.

But the signal still needs testing in broader groups and treatments.

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