Clinical trial NCT04225884: Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain
Official title: DTx for Pain: Behavioural Revalidation in Augmented and Virtual Reality for Chronic Pain; and Exploratory Pilot Study of a Virtual Reality Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-report of disability, Oswestry
timeFrame: From randomisation upto 6-8 weeks
measure: Self-report of disability; Pain Interference
timeFrame: From randomisation upto 6-8 weeks
measure: Objective report of disability, steps
timeFrame: From randomisation upto 6-8 weeks
measure: Fear of movement and re-injury
timeFrame: From randomisation upto 6-8 weeks
measure: Pain Behaviour, pain intensity
timeFrame: From randomisation upto 6-8 weeks
measure: Pain Behaviour, pain medications
timeFrame: From randomisation upto 6-8 weeks
measure: Quality of life, own experience
timeFrame: From randomisation upto 6-8 weeks
measure: Quality of life, adverse events
timeFrame: From randomisation upto 6-8 weeks
measure: Quality of life, change
timeFrame: From randomisation upto 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: CPU Orion Pharma
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Pharma Clinical Study Director
role: STUDY_DIRECTOR
References:
citation: Eccleston C, Fisher E, Liikkanen S, Sarapohja T, Stenfors C, Jaaskelainen SK, Rice ASC, Mattila L, Blom T, Bratty JR. A prospective, double-blind, pilot, randomized, controlled trial of an "embodied" virtual reality intervention for adults with low back pain. Pain. 2022 Sep 1;163(9):1700-1715. doi: 10.1097/j.pain.0000000000002617. Epub 2022 Mar 25.