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

Orion Pharma

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Standard care; Other: DTx for pain software; Other: Control software

Study type: Interventional

Funder types: Industry

Identifiers

NCT04225884

3129002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 3 patient groups

DTx for pain

Active Comparator group

Description:

Treatment A software

Treatment:

Other: DTx for pain software

Control

Sham Comparator group

Description:

Treatment B software

Treatment:

Other: Control software

Standard care

Other group

Description:

Pain medication

Treatment:

Other: Standard care