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

Abstract

IntroductionChronic 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.MethodsMovement, 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.ResultsA 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/ConclusionWe 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.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT04225884?cond=NCT04225884&draw=2&rank=1, identifier: NCT04225884.

Sensing behavior change in chronic pain: A scoping review of sensor technology for use in daily life

“…The current selection of studies used heart rate sensors (n = 6) and respiratory sensors (n = 5), with 1 study using a wearable electroencephalogram (EEG) 8 and 1 study using a commercial smart bracelet to detect electrodermal activity. 52…”

“…70,72 A recent virtual reality study using both headset and handheld sensors found changes in movement velocity to be associated with both fear of movement and reinjury and chronic low back pain. 52 This may not be due to slowed movement so much as alternative joint coordination choices 86 and stops and hesitation in movement 94 (associated with fear of movement 39,67,71 ). The relationship between fear and movement detection seems stronger when the fear of movement is measured in relation to the movement task 26,27,38 rather than the total TSK score 38,54 or pain-related anxiety 85 rather than general anxiety.…”

“…These differences in the pace of the tasks can affect the outcomes of the different kinematic measures. 86 In the studies focused on neck pain, changes in neck ROM, angular velocity, or both were related to pain intensity 1,52,77,88 and in some cases also to pain-related disability. 1,77,88 In studies of spinal, trunk, or lumbar mobility, there is at best weak evidence of a relationship between ROM or angular velocity and pain intensity 26,27,48,71,90 ; the same holds between those kinematic measures and painrelated disability.…”

“…Results of these studies in relation to psychological characteristics are mixed: some suggest that gait and posture are related to self-reported pain, depression and anxiety, 51 and fear of movement, 7,18,65 but others suggest no relationship. 48,91 Relationships found between movement kinematics and fear seemed somewhat stronger, 7,19,52,79 but not for the relationship between ROM and fear of movement (typically measured by the Tampa Scale of Kinesiophobia [TSK] 58 ) in back pain 41,48,71,91 and neck pain. 1,3,88 Task-specific fear might be expected to be more closely related to performance than broader fear of movement.…”

Artificial Intelligence for Automatic Pain Assessment: Research Methods and Perspectives

“…This wearable device is primarily used for research in fields such as psychology, neuroscience, and physiology. It is also used for monitoring stress and emotional states, as well as for tracking sleep patterns and physical activity in chronic pain rehabilitation [ 67 ], and for monitoring opioid use in patients with pain conditions [ 68 ].…”