New data from a cluster randomised controlled trial released today demonstrated that back pain patients monitored and treated using wearable movement sensors from dorsaVi (ASX:DVL) had a significant and sustained improvement in pain and functional ability.
Across all primary outcome measures, participants treated with the dorsaVi sensors with biofeedback showed a 35-47 per cent improvement at 12 months, which were all above the threshold for clinically important difference (>30 per cent of baseline scores).
The study results were published online in the leading medical journal BMC Musculoskeletal Disorders.
The journal article was authored by Associate Professor Peter Kent, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark and an independent Senior Researcher and Epidemiologist at Monash University.
It reports on the 12 month, multicentre, cluster randomised, placebo controlled clinical trial sponsored by dorsaVi and the Victorian Government.
The trial involved 112 patients – 58 in the interventional group (which received ViMove) and 54 in the control group. The results, according to the company, are highly positive and validate that intervention by ViMove resulted in “significant and sustained improvements in pain and activity limitation that persisted after treatment finished.”
This is the first clinical trial of its kind to investigate the effect that technology can have on the rehabilitation of low back pain (LBP).
The clinical trial investigated whether changing patterns of lumbo-pelvic movement and/or posture using motion sensor biofeedback, provided by ViMove, in people with LBP would lead to reduced pain and activity limitation when compared with guidelines-based medical treatment or physiotherapy.
LBP is highly prevalent and is the leading cause of disability, ahead of heart disease, chronic pulmonary musculoskeletal disorders including osteoarthritis globally. In the past, compared with placebo or no treatment, most non-surgical treatments for non-specific LBP showed only small to moderate effects with one treatment showing little superiority over the other. In addition, short term treatment effects typically reduce over the subsequent year.
According to dorsaVi CEO, Dr Andrew Ronchi, “Medical adoption by health practitioners is based on having protocols supported by clinical evidence and published in peer reviewed journals. We are delighted with the results and that it has now been published in a peer reviewed journal.”
dorsaVi’s ViMove is a wearable sensor system that turns human movement into actionable, easily interpreted data. The sensors can track a patient’s movement at 200 frames per second. The sensors provide real-time feedback about high risk positions for patients with back pain. This data informs decisions by the treating healthcare professional to modify their patients’ daily movements, thus reducing their risk of another episode and reducing recovery time. ViMove is approved for use in Australia and Europe and cleared by the FDA under 510K for the United States.