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

• ClinicalTrials.gov Identifier: NCT05701891
• Recruitment Status: Recruiting
• First Posted: January 27, 2023
• Last Update Posted: April 14, 2023
• Sponsor: HAN University of Applied Sciences
• Information provided by (Responsible Party): Bart Staal, HAN University of Applied Sciences

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)	Not Applicable

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 (Clinical Trial)
• Estimated 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.
• 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
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: March 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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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).
2. 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).
3. 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).
4. 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).
5. 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).
6. 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.
7. 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).
8. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Bart Staal, PhD; 06-55 24 06 98; bart.staal@han.nl

Locations

Netherlands

HAN University of Applied Sciences; Recruiting

Nijmegen, Netherlands, 6525EN

Sponsors and Collaborators

HAN University of Applied Sciences

  Study Documents (Full-Text)

Documents provided by Bart Staal, HAN University of Applied Sciences:

Statistical Analysis Plan  [PDF] January 27, 2023

More Information

• Responsible Party: Bart Staal, Professor (lector), HAN University of Applied Sciences
• ClinicalTrials.gov Identifier: NCT05701891
• Other Study ID Numbers: 10270032021502
• First Posted: January 27, 2023
• Last Update Posted: April 14, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bart Staal, HAN University of Applied Sciences:

Chronic low back pain; Chronic pain

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations