Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225884
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : March 4, 2020
Sponsor:
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.

Layout table for study information
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 : June 2022
Estimated Study Completion Date : June 2022

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. Objective report of disability, lumbar and spine (Modified Schober's test) [ Time Frame: From randomisation upto 6-8 weeks ]
    Clinical examination by the PI to assess the lumbar motility/movements in the spine. Lumbar motility is the increase (in centimeters) in the distance between the two marked spots (X (distance in maximally bent position) - 15 cm = Y cm (motility)). In addition, the distance of the fingertips from the floor is measured (in cm, fingers straight).

  5. Objective report of disability, lumbar and spine (Motor examination of myotomes) [ Time Frame: From randomisation upto 6-8 weeks ]
    Clinical examination by the PI to assess the lumbar motility/movements in the spine, score 0-30 (0=no muscle contraction, 30=full range of motion against gravity, maximal resistance).

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. Quality of life, adverse events [ Time Frame: From randomisation upto 6-8 weeks ]
    Adverse Event reporting, number of adverse events and their severity

  11. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Contacts
Layout table for location contacts
Contact: Orion Pharma Clinical Study Director +358 10 426 4184 clinicaltrials@orionpharma.com

Locations
Layout table for location information
Finland
CPU Orion Pharma Recruiting
Espoo, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Layout table for investigator information
Study Director: Orion Pharma Clinical Study Director Orion Corporation, Orion Pharma
Layout table for additonal information
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: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms