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

Primary Purpose

Chronic Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
DTx for pain software
Control software
Standard care
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CPU Orion Pharma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

DTx for pain

Control

Standard care

Arm Description

Treatment A software

Treatment B software

Pain medication

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
Pain Behaviour, pain intensity
Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).
Pain Behaviour, pain medications
Any changes in pain medication during the study period are reported as outcome.
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.
Quality of life, adverse events
Adverse Event reporting, number of adverse events and their severity
Quality of life, change
Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse).

Secondary Outcome Measures

Full Information

First Posted
December 20, 2019
Last Updated
September 27, 2022
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04225884
Brief Title
Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DTx for pain
Arm Type
Active Comparator
Arm Description
Treatment A software
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Treatment B software
Arm Title
Standard care
Arm Type
Other
Arm Description
Pain medication
Intervention Type
Other
Intervention Name(s)
DTx for pain software
Intervention Description
Software with active intervention
Intervention Type
Other
Intervention Name(s)
Control software
Intervention Description
Software without active intervention
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Pain medication
Primary Outcome Measure Information:
Title
Self-report of disability, Oswestry
Description
Oswestry Disability Index (subjects with a score of ≤22 will be considered as responders), index 0%-100% (0=no disability, 100=maximum disability possible).
Time Frame
From randomisation upto 6-8 weeks
Title
Self-report of disability; Pain Interference
Description
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).
Time Frame
From randomisation upto 6-8 weeks
Title
Objective report of disability, steps
Description
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).
Time Frame
From randomisation upto 6-8 weeks
Title
Fear of movement and re-injury
Description
Tampa Scale of Kinesiophobia (TSK), score 17-68 (17=negligible or no kinesiophobia,68=extreme fear of pain with movement).
Time Frame
From randomisation upto 6-8 weeks
Title
Pain Behaviour, pain intensity
Description
Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).
Time Frame
From randomisation upto 6-8 weeks
Title
Pain Behaviour, pain medications
Description
Any changes in pain medication during the study period are reported as outcome.
Time Frame
From randomisation upto 6-8 weeks
Title
Quality of life, own experience
Description
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.
Time Frame
From randomisation upto 6-8 weeks
Title
Quality of life, adverse events
Description
Adverse Event reporting, number of adverse events and their severity
Time Frame
From randomisation upto 6-8 weeks
Title
Quality of life, change
Description
Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse).
Time Frame
From randomisation upto 6-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orion Pharma Clinical Study Director
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
Facility Information:
Facility Name
CPU Orion Pharma
City
Espoo
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35324507
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.
Results Reference
derived

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

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