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

Not Applicable
Completed
Conditions
Chronic Low Back Pain
Interventions
Other: Standard care
Other: Control software
Other: 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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard careStandard carePain medication
ControlControl softwareTreatment B software
DTx for painDTx for pain softwareTreatment A software
Primary Outcome Measures
NameTimeMethod
Pain Behaviour, pain intensityFrom 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, changeFrom 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 medicationsFrom randomisation upto 6-8 weeks

Any changes in pain medication during the study period are reported as outcome.

Self-report of disability; Pain InterferenceFrom 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, stepsFrom 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-injuryFrom 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 experienceFrom 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 eventsFrom randomisation upto 6-8 weeks

Adverse Event reporting, number of adverse events and their severity

Self-report of disability, OswestryFrom 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
NameTimeMethod

Trial Locations

Locations (1)

CPU Orion Pharma

🇫🇮

Espoo, Finland

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