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Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTx for pain | Active Comparator | Treatment A software |
|
| Control | Sham Comparator | Treatment B software |
|
| Standard care | Other | Pain medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTx for pain software | Other | Software with active intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Pain Behaviour, pain medications | Any changes in pain medication during the study period are reported as outcome. | From randomisation upto 6-8 weeks |
| Quality of life, own experience |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orion Pharma Clinical Study Director | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPU Orion Pharma | Espoo | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36606032 | Derived | 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. | |
| 35324507 |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Control software |
| Other |
Software without active intervention |
|
| Standard care | Other | Pain medication |
|
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 |
| Quality of life, adverse events | Adverse Event reporting, number of adverse events and their severity | 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). | From randomisation upto 6-8 weeks |
| 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. |