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

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ClinicalTrials.gov Identifier: NCT04225884
Recruitment Status : Active, not recruiting
First Posted : January 13, 2020
Last Update Posted : September 28, 2022
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: DTx for pain software Other: Control software Other: Standard care Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: DTx for Pain: Behavioural Revalidation in Augmented and Virtual Reality for Chronic Pain; and Exploratory Pilot Study of a Virtual Reality Software
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: DTx for pain
Treatment A software
Other: DTx for pain software
Software with active intervention

Sham Comparator: Control
Treatment B software
Other: Control software
Software without active intervention

Standard care
Pain medication
Other: Standard care
Pain medication

Primary Outcome Measures :
  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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225884

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CPU Orion Pharma
Espoo, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
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Study Director: Orion Pharma Clinical Study Director Orion Corporation, Orion Pharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT04225884    
Other Study ID Numbers: 3129002
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Low Back Pain
Chronic Pain
Back Pain
Neurologic Manifestations