Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: Standard careOther: Control softwareOther: DTx for pain software
- Registration Number
- NCT04225884
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care Standard care Pain medication Control Control software Treatment B software DTx for pain DTx for pain software Treatment A software
- Primary Outcome Measures
Name Time Method Pain Behaviour, pain intensity From randomisation upto 6-8 weeks Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).
Quality of life, change 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).
Pain Behaviour, pain medications From randomisation upto 6-8 weeks Any changes in pain medication during the study period are reported as outcome.
Self-report of disability; Pain Interference 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 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 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).
Quality of life, own experience 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 From randomisation upto 6-8 weeks Adverse Event reporting, number of adverse events and their severity
Self-report of disability, Oswestry 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CPU Orion Pharma
🇫🇮Espoo, Finland