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The (cost-)effectiveness of an innovative, personalised intervention of therapeutic VirtuAl Reality IntEgrated within physioTherapY for a subgroup of complex chronic low back pain patients

The (cost-)effectiveness of an innovative, personalised intervention of therapeutic VirtuAl Reality IntEgrated within physioTherapY for a subgroup of complex chronic low back pain patients - VARIETY

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53675
Enrollment
120
Registered
2023-01-17
Start date
2023-03-31
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain

Interventions

The experimental intervention will be a personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by our partners (i.e. Reducept and SyncVR) will b

Sponsors

Hogeschool Arnhem Nijmegen (HAN)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - LBP > 3 months as reason to visit physiotherapist - absence of *red flags* or signs of specific LBP - combination of severe disability (Oswestry Disability Index (ODI) score >= 40) and severe pain (numeric rating score (NRS) >= 5) - age 18-80 years - provides informed consent

Exclusion criteria

Exclusion criteria: - severe (physical or mental) comorbidity that will substantially hinder the physiotherapy - planned diagnostic or invasive therapeutic procedure (e.g. injection, nerve block or operation) for LBP in next three months - no comprehension of Dutch language - inability to use VR (e.g. epilepsy, open wounds on face or severe visual impairment) - no supplementary health insurance - no email-address and Wi-Fi

Design outcomes

Primary

MeasureTime frame
Physical functioning (primary outcome), in addition to pain and a minimal set of other secondary clinical, adherence-related, psychological and economic measures, at baseline and 1, 3 and 12 months follow-up.

Secondary

MeasureTime frame
See protocol 6.1.2

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026