New data from a cluster randomised controlled trial has demonstrated that back pain patients monitored and treated using wearable movement sensors from dorsaVi Ltd (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 % to 47 % improvement at 12 months, which were all above the threshold for clinically important difference (>30 % of baseline scores).
The study results were published online in the leading medical journal BMC Musculoskeletal Disorders.
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, as published in the paper, 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 globally is the leading cause of disability, ahead of ischaemic heart disease, chronic obstructive pulmonary disease, and other musculoskeletal disorders, including osteoarthritis. In the UK, LBP is very common, affecting 80% of the population at some point in their lives1 and the cause of 8.3 million missed work days last year2. 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.
dorsaVi CEO, Dr Andrew Ronchi, said: "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 of the trial 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 and also encourages positive movement patterns. 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 510(k) for the United States.
About the trial
The 12 month study enrolled 112 patients at eight sites including the Austin and Epworth Hospitals. All patients reported back pain, with a vast majority (85%) classified as chronic back pain patients. All patients wore ViMove sensors and had 6-8 office visits over 10 weeks. Follow-up appointments were held at 2, 3, 6 and 12 months with their clinicians. Clinicians in the Intervention arm got access to the ViMove sensor data to guide care and their patients received real time feedback in weekly monitoring sessions. Clinicians and patients in the control group were blind to the data and were given no feedback by the ViMove device.