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

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

Detailed Description
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: DTx for pain software
* Other: Control software
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DTx for pain<br>Treatment A software | Other: DTx for pain software<br>* Software with active intervention<br>|
| Sham Comparator: Control<br>Treatment B software | Other: Control software<br>* Software without active intervention<br>|
| Other: Standard care<br>Pain medication | Other: Standard care<br>* Pain medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report of disability, Oswestry | Oswestry Disability Index (subjects with a score of ≤22 will be considered as responders), index 0%-100% (0=no disability, 100=maximum disability possible). | From randomisation upto 6-8 weeks | 
| Self-report of disability; Pain Interference | 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). | From randomisation upto 6-8 weeks | 
| Objective report of disability, steps | 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). | From randomisation upto 6-8 weeks | 
| Fear of movement and re-injury | Tampa Scale of Kinesiophobia (TSK), score 17-68 (17=negligible or no kinesiophobia,68=extreme fear of pain with movement). | From randomisation upto 6-8 weeks | 
| Pain Behaviour, pain intensity | Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain). | From randomisation upto 6-8 weeks | 
| Pain Behaviour, pain medications | Any changes in pain medication during the study period are reported as outcome. | From randomisation upto 6-8 weeks | 
| Quality of life, own experience | 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. | From randomisation upto 6-8 weeks | 
| Quality of life, adverse events | Adverse Event reporting, number of adverse events and their severity | From randomisation upto 6-8 weeks | 
| Quality of life, change | Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse). | From randomisation upto 6-8 weeks |