Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Interventions
- Other: Physiotherapy (usual care)Combination Product: Physiotherapy with integrated Virtual Reality
- Registration Number
- NCT05701891
- Lead Sponsor
- HAN University of Applied Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physiotherapy (usual care) Physiotherapy (usual care) The control condition is usual physiotherapy care for 12 weeks. Physiotherapy with integrated VR Physiotherapy with integrated Virtual Reality 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.
- Primary Outcome Measures
Name Time Method Change in physical functioning measured using the Oswestry Disability Index (ODI) 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
Name Time Method Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) baseline, 1, 3 and 12 months 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) baseline, 1, 3 and 12 months 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) baseline, 1, 3 and 12 months The PCS scores from 0 (best possible score) to 52 (worst possible score).
Change in general effect measured using the Global Perceived Effect (GPE) baseline, 1, 3 and 12 months 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) baseline and 3 months 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) baseline, 1, 3 and 12 months 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) 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).
Change in physical activity on self-reported moderate physical activity (i.e. minutes of performed physical activity in past week) 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).
Trial Locations
- Locations (1)
HAN University of Applied Sciences
🇳🇱Nijmegen, Netherlands