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

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Physiotherapy with integrated Virtual Reality
Physiotherapy (usual care)
Sponsored by
HAN University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic low back pain, Chronic pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • HAN University of Applied SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physiotherapy with integrated VR

Physiotherapy (usual care)

Arm 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.

The control condition is usual physiotherapy care for 12 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2022
Last Updated
April 12, 2023
Sponsor
HAN University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05701891
Brief Title
Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain
Acronym
VARIETY
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HAN University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic low back pain, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy with integrated VR
Arm Type
Experimental
Arm 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.
Arm Title
Physiotherapy (usual care)
Arm Type
Active Comparator
Arm Description
The control condition is usual physiotherapy care for 12 weeks.
Intervention Type
Combination Product
Intervention Name(s)
Physiotherapy with integrated Virtual Reality
Other Intervention Name(s)
Reducept, SyncVR Relax & Distract, SyncVR Fit
Intervention Description
A 12-week personalised, VR-integrated physiotherapy intervention.
Intervention Type
Other
Intervention Name(s)
Physiotherapy (usual care)
Intervention Description
A 12-week usual physiotherapy care intervention.
Primary Outcome Measure Information:
Title
Change in physical functioning measured using the Oswestry Disability Index (ODI)
Description
This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).
Time Frame
baseline, 1, 3 and 12 months
Secondary Outcome Measure Information:
Title
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
Description
This questionnaire on pain intensity scores from 0 (best possible score) to 10 (worst possible score).
Time Frame
baseline, 1, 3 and 12 months
Title
Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)
Description
The FABQ scores from 0 (best possible score) to 30 (worst possible score).
Time Frame
baseline, 1, 3 and 12 months
Title
Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)
Description
The PCS scores from 0 (best possible score) to 52 (worst possible score).
Time Frame
baseline, 1, 3 and 12 months
Title
Change in physical activity on self-reported moderate physical activity (i.e. minutes of performed physical activity in past week)
Description
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).
Time Frame
baseline, 1, 3 and 12 months
Title
Change in general effect measured using the Global Perceived Effect (GPE)
Description
This questionnaire scores from 0 (worst possible score) to 14 (best possible score).
Time Frame
baseline, 1, 3 and 12 months
Title
Change in problems with activities measured using the Patient Specific Complaints (PSK)
Description
This questionnaire scores from 0 (best possible score) to 10 (worst possible score) per activity.
Time Frame
baseline and 3 months
Title
Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ)
Description
This questionnaire scores from 0 (worst possible score) to 60 (best possible score).
Time Frame
baseline, 1, 3 and 12 months
Title
Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L)
Description
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).
Time Frame
baseline, 1, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bart Staal, PhD
Phone
06-55 24 06 98
Email
bart.staal@han.nl
Facility Information:
Facility Name
HAN University of Applied Sciences
City
Nijmegen
ZIP/Postal Code
6525EN
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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