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

NCT05701891 | Unknown

• 1 other identifier: 10270032021502
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic low back pain; Chronic pain

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline, 1, 3 and 12 months

Secondary Outcomes (8)

• Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)

  baseline, 1, 3 and 12 months

• Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)

  baseline, 1, 3 and 12 months

• Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)

  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)

  baseline, 1, 3 and 12 months

• Change in general effect measured using the Global Perceived Effect (GPE)

  baseline, 1, 3 and 12 months

Study Arms (2)

Physiotherapy with integrated VR

EXPERIMENTAL

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

Physiotherapy (usual care)

ACTIVE COMPARATOR

The control condition is usual physiotherapy care for 12 weeks.

Other: Physiotherapy (usual care)

Interventions

Physiotherapy with integrated Virtual Reality COMBINATION_PRODUCT

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

Also known as: Reducept, SyncVR Relax & Distract, SyncVR Fit

Physiotherapy with integrated VR

Physiotherapy (usual care) OTHER

A 12-week usual physiotherapy care intervention.

Physiotherapy (usual care)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HAN University of Applied Sciences: lead

Study Sites (1)

HAN University of Applied Sciences

Nijmegen, 6525EN, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 36803315 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Bart Staal, PhD

CONTACT

06-55 24 06 98; bart.staal@han.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (lector)

Model Details: This study is a two-arm cluster-randomized controlled trial. Twenty physiotherapists with expertise in chronic LBP treatment will be recruited and equally randomised (10 in each arm) on the level of physiotherapy practice using allocation concealment. This clustered design means that eligible patients consulting a participating physiotherapist will be automatically allocated to the study arm (experimental or control arm) to which the physiotherapy practice was allocated.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 27, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)