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 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Other: DTx for pain software Other: Control software Other: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Other: Standard care
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.
- 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.
- Quality of life, adverse events [ Time Frame: From randomisation upto 6-8 weeks ]Adverse Event reporting, number of adverse events and their severity
- 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).
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
|CPU Orion Pharma|
|Study Director:||Orion Pharma Clinical Study Director||Orion Corporation, Orion Pharma|