Our primary objective is to investigate whether a personalised, physiotherapy intervention with integrated therapeutic virtual reality (VR) is (cost-)effective at 3 months and 12 months follow-up, compared to usual physiotherapy, in a subgroup of…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
See protocol 6.1.2
Background summary
Physiotherapy, mainly consisting of exercise therapy and patient education, is
a first-choice primary care treatment for patients with chronic low back pain
(LBP), but unfortunately, especially patients with severe disability and pain
demonstrate poor outcomes. Therapeutic VR is considered a potential
breakthrough for LBP patients in general and for our complex group of patients
with severe disability and pain in particular, as it specifically targets the
identified limitations of usual physiotherapy. Therefore, a personalised,
VR-integrated physiotherapy intervention, tailored to specific patient
characteristics, is expected to result in larger improvements in physical
functioning and pain, and more favourable cost-effectiveness, compared to usual
physiotherapy.
Study objective
Our primary objective is to investigate whether a personalised, physiotherapy
intervention with integrated therapeutic virtual reality (VR) is
(cost-)effective at 3 months and 12 months follow-up, compared to usual
physiotherapy, in a subgroup of patients with complex chronic low back pain
(LBP) and severe disability and pain.
Study design
Cluster randomised controlled trial.
Intervention
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 be integrated into
physiotherapy based on the recommendations of the LBP guidelines. The control
intervention will be physiotherapy as usual.
Study burden and risks
Participants from the control arm will be treated as usual by their
physiotherapist, whereas participants from the experimental arm will receive
the experimental, VR-integrated intervention by a trained physiotherapist, with
no extra risks as compared to the regular delivery of primary care
physiotherapy. The burden of the participants will be minimized to the time
necessary for completing the questionnaires (approximately 1.5 hours in total)
and the visits with the physiotherapist. Furthermore, for participants with a
sufficient supplementary health insurance, the costs of the treatments from the
physiotherapist will be compensated. Patients without or with an insufficient
supplementary health insurance shall pay for the treatments themselves
(approximately 30 euros per treatment). Measurements are limited to
self-reported questionnaires, therefore not having any risk either.
Lindestraat 30
Oldenzaal 7572TV
NL
Lindestraat 30
Oldenzaal 7572TV
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82072.091.22 |