A novel treatment, a digital therapeutics software solution for Chronic Pain (DTxP), has shown statistically significant benefit over passive (placebo) control and standard care interventions for fear of movement, patient clinical global impression of change (PGIC) and quality of life in adult patients with chronic low back pain (CLBP). Results from Orion Corporation’s pilot study ‘VIRPI’ were announced at the IASP 2021 Virtual World Congress On Pain.

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 (-9.4 to -0.1, p=0.046) and increased when compared to standard care -6.1 (-10.9 to -1.3, p=0.014). Patient clinical global impression of change (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.

Non-statistically significant improvements were reported with DTxP for Oswestry Disability Index (ODI), pain interference (Patient-Reported Outcomes Information System: PROMIS), and pain intensity (PROMIS-Numerical Rating Scale). Adverse effects appeared acceptable and similar to passive control.

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 (DTx) 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, says Sammeli Liikkanen, Director of Digital Medicine at Orion Corporation.

Cognitive Behavioral 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, says Christopher Eccleston, Professor of Pain Research at University of Bath.

Orion is looking for a partner to further develop and commercialise Orion’s digital therapeutics software solution for Chronic Pain.

Orion’s digital therapeutics software solution for Chronic Pain (DTxP)

Orion’s DTxP, aimed to be a software as medical device (SaMD), is built for virtual reality (VR) devices to provide an immersive gamified therapeutic treatment program 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 is designed to be flexible and to be used as a part of multiple different treatment approaches. It also provides objective data to patients and treating healthcare professionals. As an example, gamified physical movements with proven safety targeted to encourage movement can lead one to overcome 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.

The VIRPI trial design

The VIRPI trial is a prospective, randomised, double-blind, 3-arm parallel group comparison of DTxP, passive control (a placebo “sham” running on VR specifically developed for this purpose) and an open standard care arm evaluating the safety and efficacy of DTxP in patients with chronic low back pain (CLBP). Inclusion criteria were low back pain for at least 3 months, average pain intensity of ≥4 over the past week on a 0–10 Numerical Rating Scale (NRS), Oswestry Disability Index (ODI) of ≥26%, and medium (34-41) or high (42-68) Tampa Scale for Kinesiophobia (TSK) score.

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 5 or more days per week up to the end-of-intervention (EOI). EOI was defined as the completion of 30 modules of DTxP or passive control, which took 6-8 weeks. Approximately 3 months after the EOI, information about pain status, disability, kinesiophobia, overall status and any adverse event (AE) were collected as follow-up data. Quality of life (QoL) was evaluated with the EQ-5D-5L questionnaire. The third group, randomly assigned to the standard care arm, visited the site for screening on Day 1 and 6-8 weeks after randomisation. After week 9 follow-up visit, the participants were re-randomised between DTxP and passive control for the next 6-8 weeks, followed by a 3-month follow-up period.