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A novel digital therapeutics software, DTxP, has shown statistically significant benefits for patients with chronic low back pain (CLBP) in trials, lowering fear of movement, improving patient clinical global impression of change (PGIC), and improving quality of life.
DTxP was designed to be a software as medical device (SaMD), and is built for virtual reality (VR) devices to provide an immersive gamified therapeutic treatment programme for the chronic pain patients. The product contains behaviour change advice and instruction, presented as modules that can be tailored to the patients’ needs.
The product provides objective data to patients and treating healthcare professionals with gamified physical movements with proven safety targeted to encourage movement which can lead one to overcoming the fear of movement, and so increase activity.
The software has been developed by Orion in close collaboration with external scientific advisor Christopher Eccleston from University of Bath, and technology partner Healthware Group, with support from Business Finland.
Eccleston said: “Cognitive Behavioural Therapy (CBT) is scientifically sound, effective, and a recommended method to improve the self-management of chronic pain. For many suffering with difficult pain and disability, it is one option to reverse the decline in loss of function, and help people return to valued goals and activities.
“However, the access to qualified practitioners is very limited and getting smaller as the number of people with pain grows. DTx solutions operating within a CBT framework could bring new treatment options, potentially more powerful treatment options, to a larger population of patients.”
Results from the VIRPI study in patients with CLBP showed that TSK score (Tampa Scale for Kinesiophobia assessing fear of movement) was significantly reduced at the end-of-intervention (EOI) for DTxP. Primary analysis for the difference between DTxP and passive control at EOI was statistically significant: -4.7 points and increased when compared to standard care -6.1.
PGIC, which reflects a patient’s belief about the efficacy of the treatment, and their quality of life (QoL) also reached a statistically significant difference at EOI in comparison to passive control and standard care groups.
A total of 42 patients were randomised to receive DTxP (14), passive control (17) or standard care (11). Participants undertook DTxP or passive control for 15-60 minutes at a time, on five or more days per week up to the EOI.
Sammeli Liikkanen, Director of Digital Medicine at Orion Corporation, said: “There is an unmet need for novel therapies in the treatment of chronic pain. The currently available treatments may provide suboptimal efficacy and tolerability to certain patients. Digital therapeutics is a new and rapidly evolving treatment paradigm, also for pain. We are exploring different solutions, such as this DTxP, for the future of pain care.”
Kat Jenkins
This is a syndicated feed from Pharmafile