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

Sponsor

HAN University of Applied Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701891

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Combination Product: Physiotherapy with integrated Virtual Reality Other: Physiotherapy (usual care)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The (Cost-)Effectiveness of an Innovative, Personalised Intervention of Therapeutic VirtuAl Reality IntEgrated Within physioTherapY for a Subgroup of Complex Chronic Low Back Pain Patients

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Combination Product: Physiotherapy with integrated Virtual Reality A 12-week personalised, VR-integrated physiotherapy intervention. Other Names: Reducept SyncVR Relax & Distract SyncVR Fit
Active Comparator: Physiotherapy (usual care) The control condition is usual physiotherapy care for 12 weeks.	Other: Physiotherapy (usual care) A 12-week usual physiotherapy care intervention.

Arm

Intervention/Treatment

Experimental: 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.

Combination Product: Physiotherapy with integrated Virtual Reality

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

Other Names:

Reducept

SyncVR Relax & Distract

SyncVR Fit

Active Comparator: Physiotherapy (usual care)

The control condition is usual physiotherapy care for 12 weeks.

Other: Physiotherapy (usual care)

A 12-week usual physiotherapy care intervention.

Outcome Measures

Primary Outcome Measures

Change in physical functioning measured using the Oswestry Disability Index (ODI) [baseline, 1, 3 and 12 months]
This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).

Secondary Outcome Measures

Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) [baseline, 1, 3 and 12 months]
This questionnaire on pain intensity scores from 0 (best possible score) to 10 (worst possible score).
Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA) [baseline, 1, 3 and 12 months]
The FABQ scores from 0 (best possible score) to 30 (worst possible score).
Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS) [baseline, 1, 3 and 12 months]
The PCS scores from 0 (best possible score) to 52 (worst possible score).
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]
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).
Change in general effect measured using the Global Perceived Effect (GPE) [baseline, 1, 3 and 12 months]
This questionnaire scores from 0 (worst possible score) to 14 (best possible score).
Change in problems with activities measured using the Patient Specific Complaints (PSK) [baseline and 3 months]
This questionnaire scores from 0 (best possible score) to 10 (worst possible score) per activity.
Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ) [baseline, 1, 3 and 12 months]
This questionnaire scores from 0 (worst possible score) to 60 (best possible score).
Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L) [baseline, 1, 3, 6 and 12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

HAN University of Applied Sciences

Investigators

None specified.

Study Documents (Full-Text)

Statistical Analysis Plan - Jan 27, 2023

More Information

Publications

None provided.

Responsible Party:

Bart Staal, Professor (lector), HAN University of Applied Sciences

ClinicalTrials.gov Identifier:

NCT05701891

Other Study ID Numbers:

10270032021502

First Posted:

Jan 27, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bart Staal, Professor (lector), HAN University of Applied Sciences

Chronic low back pain

Chronic pain

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Jan 31, 2023