Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain (VARIETY)

HAN University of Applied Sciences

Status: Enrolling

Conditions: Chronic Low-back Pain

Treatments: Combination Product: Physiotherapy with integrated Virtual Reality; Other: Physiotherapy (usual care)

Study type: Interventional

Funder types: Other

Identifiers

NCT05701891

10270032021502

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 ≥ 30) 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 email-address and Wi-Fi

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Physiotherapy with integrated VR

Experimental group

Description:

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.

Treatment:

Combination Product: Physiotherapy with integrated Virtual Reality

Physiotherapy (usual care)

Active Comparator group

Description:

The control condition is usual physiotherapy care for 12 weeks.

Treatment:

Other: Physiotherapy (usual care)