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

Chronic Low-back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701891
• Other study ID #: 10270032021502
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2023
• Source: HAN University of Applied Sciences
• Contact: Bart Staal, PhD
• Phone: 06-55 24 06 98
• Email: bart.staal[@]han.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Combination Product:
• Physiotherapy with integrated Virtual Reality
A 12-week personalised, VR-integrated physiotherapy intervention.

Other:
• Physiotherapy (usual care)
A 12-week usual physiotherapy care intervention.

Locations

Country	Name	City	State
Netherlands	HAN University of Applied Sciences	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
HAN University of Applied Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	baseline, 1, 3 and 12 months
Secondary	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).	baseline, 1, 3 and 12 months
Secondary	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).	baseline, 1, 3 and 12 months
Secondary	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).	baseline, 1, 3 and 12 months
Secondary	Change in general effect measured using the Global Perceived Effect (GPE)	This questionnaire scores from 0 (worst possible score) to 14 (best possible score).	baseline, 1, 3 and 12 months
Secondary	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.	baseline and 3 months
Secondary	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).	baseline, 1, 3 and 12 months
Secondary	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).	baseline, 1, 3, 6 and 12 months