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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in physical functioning measured using the Oswestry Disability Index (ODI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Physiotherapy with integrated Virtual Reality (Combination Product)
Physiotherapy (usual care)
The control condition is usual physiotherapy care for 12 weeks.
干预措施: Physiotherapy (usual care) (Other)
结局指标
主要结局
Change in physical functioning measured using the Oswestry Disability Index (ODI)
时间窗: baseline, 1, 3 and 12 months
This questionnaire on physical functioning scores from 0 (best possible score) to 100 (worst possible score).
次要结局
- Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)(baseline, 1, 3 and 12 months)
- Change in pain-related fears measured using the Fear-Avoidance Beliefs Questionnaire - Physical Activity (FABQ-PA)(baseline, 1, 3 and 12 months)
- Change in pain-related fears measured using the Pain Catastrophizing Scale (PCS)(baseline, 1, 3 and 12 months)
- Change in general effect measured using the Global Perceived Effect (GPE)(baseline, 1, 3 and 12 months)
- Change in problems with activities measured using the Patient Specific Complaints (PSK)(baseline and 3 months)
- Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ)(baseline, 1, 3 and 12 months)
- Change in cost-effectiveness measured using the EuroQol - 5 Dimensions - 5 Level (EQ-5D-5L)(baseline, 1, 3, 6 and 12 months)
- 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)
研究者
Bart Staal
Professor (lector)
HAN University of Applied Sciences