Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain

Orion Corporation, Orion Pharma34 enrolled

Overview

Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.

Prospective, randomised, double-blind, 3-arm parallel group comparison of DTx for pain (treatment A), control (treatment B) and an open standard care arm, over 6-8 weeks. An optional adaptive, multi-objective, multi-purpose, extension is included. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote technical support.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Low Back Pain

Interventions

DTx for pain softwareOTHER

Software with active intervention

Control softwareOTHER

Software without active intervention

Standard careOTHER

Pain medication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Competent male or female adults (age ≥ 18 years). * Chronic low back pain * Written informed consent * Finnish speaking * having a clear, flat surface of at least 2 x 2 m of size to interact with DTx for pain * Can stoop without severe pain Exclusion Criteria: * History of epilepsy, migraine, vertigo or psychosis * Confirmed diagnosis of cancer * Prone to strong motion sickness requiring treatment * Pregnancy * Physiotherapy based interventions contraindicated * Severe or acute structural pathologies (e.g. spondylitis, epidural abscess, spondylolisthesis, acute herniated or ruptured disc, traumatic injury, or severe spinal stenosis) that could be worsened by the intervention as assessed by the principal investigator * Has received (in last 2 years) or is receiving formal psychotherapy from a psychologist for pain or allied health care professional at the screening stage * Any other condition that would affect posture or balance, and * Prior participation in DTx for pain feasibility study or in any part of the current study

Locations (1)

CPU Orion Pharma

Espoo, Finland

Outcomes

Primary Outcomes

Self-report of disability, Oswestry

Oswestry Disability Index (subjects with a score of ≤22 will be considered as responders), index 0%-100% (0=no disability, 100=maximum disability possible).