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Completed

NCT Number: NCT04225884

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

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

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPU Orion Pharma

Espoo, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DTx for pain software

Other

Software with active intervention

Control software

Other

Software without active intervention

Standard care

Other

Pain medication

Primary outcomes

  1. Self-report of disability, Oswestry

    Time frame: From randomisation upto 6-8 weeks

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

  2. Self-report of disability; Pain Interference

    Time frame: From randomisation upto 6-8 weeks

    The Patient Reported Outcomes Information System (PROMIS) 6b - Pain Interference Scale, score 6-30 (6=pain not at all interfering patient's life, 30=maximum interfering to patient's life).

  3. Objective report of disability, steps

    Time frame: From randomisation upto 6-8 weeks

    Average number of steps per day over one week, as assessed by wearable equipment, 0-maximum amount of steps (0=patient not taking steps at all, maximum disability; maximum number of steps=minimum disability).

  4. Fear of movement and re-injury

    Time frame: From randomisation upto 6-8 weeks

    Tampa Scale of Kinesiophobia (TSK), score 17-68 (17=negligible or no kinesiophobia,68=extreme fear of pain with movement).

  5. Pain Behaviour, pain intensity

    Time frame: From randomisation upto 6-8 weeks

    Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).

  6. Pain Behaviour, pain medications

    Time frame: From randomisation upto 6-8 weeks

    Any changes in pain medication during the study period are reported as outcome.

  7. Quality of life, own experience

    Time frame: From randomisation upto 6-8 weeks

    EuroQol-5D-5L-scale: European Quality (EQ) of Life (l), 5-dimension-5-level-scale. a). Descriptive System, 5-dimension-5-level-scale, scores are converted to a value where 1 equals 'perfect health' and 0 equals 'dead'. b). Visual Analogue Score, score 0 to 100 where 100 is the best health you can imagine and 0 = the worst health you can imagine.

  8. Quality of life, adverse events

    Time frame: From randomisation upto 6-8 weeks

    Adverse Event reporting, number of adverse events and their severity

  9. Quality of life, change

    Time frame: From randomisation upto 6-8 weeks

    Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse).

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

DTx for Pain: Behavioural Revalidation in Augmented and Virtual Reality for Chronic Pain; and Exploratory Pilot Study of a Virtual Reality Software

Acronym: VIRPI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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