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

April 12, 2023 updated by: Bart Staal, HAN University of Applied Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6525EN
        • Recruiting
        • HAN University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HAN University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10270032021502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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