Chronic Low Back PainVIRPINCT04225884
Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain
A study testing DTx for pain software in people with Chronic Low Back Pain, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- DTx for pain software
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFinland
- Study dates
- 4 Feb 2020to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DTx for Pain: Behavioural Revalidation in Augmented and Virtual Reality for Chronic Pain; and Exploratory Pilot Study of a Virtual Reality Software
Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- DTx for pain software, Control software, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTx for pain softwareOther
Software with active intervention
Control softwareOther
Software without active intervention
Standard careOther
Pain medication
| Study group | Role | What they receive |
|---|---|---|
| DTx for pain | Active comparator | Treatment A software Receives: Other: DTx for pain software |
| Control | Sham comparator | Treatment B software Receives: Other: Control software |
| Standard care | Other | Pain medication Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From randomisation upto 6-8 weeks
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).
Measured: From randomisation upto 6-8 weeks
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).
Measured: From randomisation upto 6-8 weeks
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).
Measured: From randomisation upto 6-8 weeks
Pain Behaviour, pain intensity
Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).
Measured: From randomisation upto 6-8 weeks
Pain Behaviour, pain medications
Any changes in pain medication during the study period are reported as outcome.
Measured: From randomisation upto 6-8 weeks
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.
Measured: From randomisation upto 6-8 weeks
Quality of life, adverse events
Adverse Event reporting, number of adverse events and their severity
Measured: From randomisation upto 6-8 weeks
Quality of life, change
Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse).
Measured: From randomisation upto 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start4 Feb 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orion Pharma Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225884
- Sponsor's protocol ID
- 3129002
- Acronym
- VIRPI
- Status last verified
- Nov 2023
- First submitted
- 20 Dec 2019
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liikkanen S, Makinen M, Huttunen T, Sarapohja T, Stenfors C, Eccleston C. Body movement as a biomarker for use in chronic pain rehabilitation: An embedded analysis of an RCT of a virtual reality solution for adults with chronic pain. Front Pain Res (Lausanne). 2022 Dec 20;3:1085791. doi: 10.3389/fpain.2022.1085791. eCollection 2022.
PubMed 36606032Eccleston 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.
PubMed 35324507
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DTx for Pain: Behavioural Revalidation in Augmented and Virtual Reality for Chronic Pain; and Exploratory Pilot Study of a Virtual Reality Software
- ClinicalTrials.gov ID
- NCT04225884
- Acronym / sponsor ID
- VIRPI / 3129002
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DTx for pain | Active comparator | Other: DTx for pain softwareTreatment A software |
| Control | Sham comparator | Other: Control softwareTreatment B software |
| Standard care | Other | Other: Standard carePain medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- History of epilepsy, migraine, vertigo or psychosis
- Confirmed diagnosis of cancer
- Prone to strong motion sickness requiring treatment
- Pregnancy
- Physiotherapy based interventions contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTx for pain softwareSoftware with active intervention | Other | DTx for pain |
| Control softwareSoftware without active intervention | Other | Control |
| Standard carePain medication | Other | Standard care |
Primary outcome
Self-report of disability, Oswestry
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From randomisation upto 6-8 weeks
Any changes in pain medication during the study period are reported as outcome.
Quality of life, own experience
Time frame: 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
Time frame: From randomisation upto 6-8 weeks
Adverse Event reporting, number of adverse events and their severity
Quality of life, change
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 36606032Liikkanen S, Makinen M, Huttunen T, Sarapohja T, Stenfors C, Eccleston C. Body movement as a biomarker for use in chronic pain rehabilitation: An embedded analysis of an RCT of a virtual reality solution for adults with chronic pain. Front Pain Res (Lausanne). 2022 Dec 20;3:1085791. doi: 10.3389/fpain.2022.1085791. eCollection 2022.
- Derived from this study: PubMed 35324507Eccleston 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orion Pharma Clinical Study Director study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTx for pain software in people with Chronic Low Back Pain, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of disability, Oswestry (time frame: From randomisation upto 6-8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225884, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.