Clinical trial NCT05701891: Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic low back pain
Chronic pain
Lead sponsor: HAN University of Applied Sciences
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in physical functioning measured using the Oswestry Disability Index (ODI)
timeFrame: baseline, 1, 3 and 12 months
Secondary outcomes:
measure: Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
timeFrame: baseline, 1, 3 and 12 months
measure: Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)
timeFrame: baseline, 1, 3 and 12 months
measure: Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)
timeFrame: baseline, 1, 3 and 12 months
measure: Change in physical activity on self-reported moderate physical activity (i.e. minutes of performed physical activity in past week)
timeFrame: baseline, 1, 3 and 12 months
measure: Change in general effect measured using the Global Perceived Effect (GPE)
timeFrame: baseline, 1, 3 and 12 months
measure: Change in problems with activities measured using the Patient Specific Complaints (PSK)
timeFrame: baseline and 3 months
measure: Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: baseline, 1, 3 and 12 months
measure: Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L)
timeFrame: baseline, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: HAN University of Applied Sciences
Study officials:
References: