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

Chronic Low Back Pain Clinical Trial

— VIRPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225884
• Other study ID #: 3129002
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Other:
• DTx for pain software
Software with active intervention
• Control software
Software without active intervention
• Standard care
Pain medication

Locations

Country	Name	City	State
Finland	CPU Orion Pharma	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Pain Behaviour, pain medications	Any changes in pain medication during the study period are reported as outcome.	From randomisation upto 6-8 weeks
Primary	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
Primary	Quality of life, adverse events	Adverse Event reporting, number of adverse events and their severity	From randomisation upto 6-8 weeks
Primary	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