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

NCT ID: NCT05701891

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-31

Brief Summary

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.

Detailed 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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapy with integrated VR

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.

Group Type: EXPERIMENTAL

Physiotherapy with integrated Virtual Reality

Intervention Type: COMBINATION_PRODUCT

A 12-week personalised, VR-integrated physiotherapy intervention.

Physiotherapy (usual care)

The control condition is usual physiotherapy care for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Physiotherapy (usual care)

Intervention Type: OTHER

A 12-week usual physiotherapy care intervention.

Interventions

Physiotherapy with integrated Virtual Reality

A 12-week personalised, VR-integrated physiotherapy intervention.

Intervention Type: COMBINATION_PRODUCT

Physiotherapy (usual care)

A 12-week usual physiotherapy care intervention.

Intervention Type: OTHER

Other Intervention Names

Reducept; SyncVR Relax & Distract; SyncVR Fit

Eligibility 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 ≥ 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAN University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Bart Staal

Professor (lector)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HAN University of Applied Sciences

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bart Staal, PhD

Role: CONTACT

bart.staal@han.nl

06-55 24 06 98

References

Slatman S, Ostelo R, van Goor H, Staal JB, Knoop J. Physiotherapy with integrated virtual reality for patients with complex chronic low back pain: protocol for a pragmatic cluster randomized controlled trial (VARIETY study). BMC Musculoskelet Disord. 2023 Feb 20;24(1):132. doi: 10.1186/s12891-023-06232-0.

Reference Type: DERIVED

PMID: 36803315 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

10270032021502

Identifier Type: -

Identifier Source: org_study_id