An interventional study of Physiotherapy with integrated Virtual Reality and Physiotherapy (usual care) in Chronic Low-back Pain, sponsored by HAN University of Applied Sciences. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by HAN University of Applied Sciences · Not applicable, Interventional, and Treatment
This study examines the effect of a 12-week intervention of physiotherapy with integrated Virtual Reality (VR) on 120 patients with complex chronic low back pain. Patients in the intervention group will receive physiotherapy with integrated VR, while patients in the control group will receive physiotherapy as usual. The (cost-)effectiveness of this intervention will be investigated at 3 months and 12 months follow-up.
Rationale: 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.
Objective: The 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.
Study population: 120 chronic LBP patients with combination of severe disability and severe pain, consulting a physiotherapist in primary care.
Intervention: The experimental intervention will be a 12-week personalised, VR-integrated physiotherapy intervention in which a selection of existing VR modules developed by research 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.
Main study parameters/endpoints: 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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →HAN University of Applied Sciences is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Our intervention will be a 12-week 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 treatment. The following VR modules will be used: education (Reducept), relaxation and distraction (SyncVR Relax \& Distract), activation (SyncVR Fit). Patients will use the Pico Neo 3 VR headset at the physiotherapy practice and at home 5 days a week for 10-30 minutes. In addition, physiotherapists will help patients transition from movements performed in a VR context to daily activities without VR.
Combination Product: Physiotherapy with integrated Virtual Reality
The control condition is usual physiotherapy care for 12 weeks.
Other: Physiotherapy (usual care)
A 12-week personalised, VR-integrated physiotherapy intervention.
Also known as: Reducept, SyncVR Relax & Distract, SyncVR Fit
A 12-week usual physiotherapy care intervention.
Change in physical functioning measured using the Oswestry Disability Index (ODI)
This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).
Time frame: baseline, 1, 3 and 12 months
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
This questionnaire on pain intensity scores from 0 (best possible score) to 10 (worst possible score).
Time frame: baseline, 1, 3 and 12 months
Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)
The FABQ scores from 0 (best possible score) to 30 (worst possible score).
Time frame: baseline, 1, 3 and 12 months
Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)
The PCS scores from 0 (best possible score) to 52 (worst possible score).
Time frame: baseline, 1, 3 and 12 months
Change in physical activity on self-reported moderate physical activity (i.e. minutes of performed physical activity in past week)
This questionnaire scores from 0 minutes (worst possible score) to 1680 minutes (best possible score, based on a maximum of 4 hours of possible moderate physical activity per day).
Time frame: baseline, 1, 3 and 12 months
Change in general effect measured using the Global Perceived Effect (GPE)
This questionnaire scores from 0 (worst possible score) to 14 (best possible score).
Time frame: baseline, 1, 3 and 12 months
Change in problems with activities measured using the Patient Specific Complaints (PSK)
This questionnaire scores from 0 (best possible score) to 10 (worst possible score) per activity.
Time frame: baseline and 3 months
Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ)
This questionnaire scores from 0 (worst possible score) to 60 (best possible score).
Time frame: baseline, 1, 3 and 12 months
Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L)
The questionnaire consists of two components: the EQ-5D descriptive system and the EQ Visual Analogue Scale (EQ-VAS).The first part consists of five subjects, from which for each subject a single EQ-5D index score can be calculated ranging from 0 (worst possible score) to 1 (best possible score). The EQ-VAS scores from 0 (worst possible score) to 100 (best possible score).
Time frame: baseline, 1, 3, 6 and 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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HAN University of Applied Sciences