Chronic Low Back Pain
Conditions
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.
Interventions
OTHERDTx for pain software
Software with active intervention
OTHERControl software
Software without active intervention
OTHERStandard care
Pain medication
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| Pain Behaviour, pain medications | From randomisation upto 6-8 weeks | Any changes in pain medication during the study period are reported as outcome. |
| 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 |
| 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). |
Countries
Finland
Outcome results
None listed