School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada
Orthopaedic Clinical Research Unit, Maisonneuve-Rosemont Hospital Research Center, Montreal, Quebec, Canada.
BMJ Open. 2021 Sep 7;11(9):e053004. doi: 10.1136/bmjopen-2021-053004.
To assess the effectiveness and cost-effectiveness of a single session compared with multiple sessions of education and exercise for older adults with spinal pain treated conservatively in an advanced practice physiotherapy model of care.
In this pragmatic randomised controlled trial, 152 older adults (≥65 years old) with neck or back pain initially referred for a consultation in neurosurgery, but treated conservatively, will be recruited through the advanced practice physiotherapy neurosurgery CareAxis programme in the Montreal region (Quebec, Canada). In the CareAxis programme, older patients with spinal pain are triaged by an advance practice physiotherapist and are offered conservative care and only potential surgical candidates are referred to a neurosurgeon. Participants will be randomised into one of two arms: 1-a single session or 2-multiple sessions (6 sessions over 12 weeks) of education and exercise with the advance practice physiotherapist (1:1 ratio). The primary outcome measure will be the Brief Pain Inventory (pain severity and interference subscales). Secondary measures will include self-reported disability (the Neck Disability Index or Oswestry Disability Index), the Pain Catastrophizing Scale, satisfaction with care questionnaires (9-item Visit-specific Satisfaction Questionnaire and MedRisk), and the EQ-5D-5L. Participants' healthcare resources use and related costs will be measured. Outcomes will be collected at baseline and at 6, 12 and 26 weeks after enrolment. Intention-to-treat analyses will be performed, and repeated mixed-model analysis of variance will assess differences between treatment arms. Cost-utility analyses will be conducted from the perspective of the healthcare system.
Ethics approval has been obtained from the (FWA00001935 and IRB00002087). Results of this study will be presented to different stakeholders, published in peer-reviewed journals and presented at international conferences.
V.4 August 2021.
NCT04868591; Pre-results.
评估单次治疗与多次治疗在接受高级实践物理治疗的保守治疗模式下的老年脊柱疼痛患者中的有效性和成本效益。
在这项实用随机对照试验中，将通过蒙特利尔地区（加拿大魁北克省）的高级实践物理治疗神经外科 CareAxis 计划招募 152 名（≥65 岁）颈痛或背痛的老年患者（最初转介至神经外科就诊，但接受保守治疗）。在 CareAxis 计划中，由高级实践物理治疗师对脊柱疼痛的老年患者进行分诊，并提供保守治疗，仅将潜在的手术患者转介给神经外科医生。参与者将被随机分配到两个治疗组之一：1-单次治疗或 2-与高级实践物理治疗师进行多次治疗（12 周内进行 6 次治疗）（1:1 比例）。主要结局指标将是简短疼痛量表（疼痛严重程度和干扰子量表）。次要指标包括自我报告的残疾（颈部残疾指数或 Oswestry 残疾指数）、疼痛灾难化量表、护理满意度问卷（9 项特定就诊满意度问卷和 MedRisk）和 EQ-5D-5L。将测量参与者的医疗资源使用情况和相关成本。将在基线和入组后 6、12 和 26 周收集结果。将进行意向治疗分析，并使用重复混合模型方差分析评估治疗组之间的差异。将从医疗保健系统的角度进行成本效用分析。
已从不同利益相关者获得伦理批准，将在同行评审期刊上发表，并在国际会议上展示。
V.4 2021 年 8 月。
NCT04868591；预结果。
