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后路手术或脑路手术治疗腰椎神经根病患者?一项随机对照试验方案。

Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial.

机构信息

Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy (KIMA), Vrije Universiteit Brussel; Department of Physical Medicine and Physiotherapy, University Hospital Brussels.

Department of Neurosurgery, University Hospital Brussels; Department of Manual Therapy (MANU), Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel.

出版信息

J Physiother. 2016 Jul;62(3):165. doi: 10.1016/j.jphys.2016.05.009. Epub 2016 Jun 11.


DOI:10.1016/j.jphys.2016.05.009
PMID:27298051
Abstract

INTRODUCTION: Despite scientific progress with regard to pain neuroscience, perioperative education tends to stick to the biomedical model. This may involve, for example, explaining the surgical procedure or 'back school' (education that focuses on biomechanics of the lumbar spine and ergonomics). Current perioperative education strategies that are based on the biomedical model are not only ineffective, they can even increase anxiety and fear in patients undergoing spinal surgery. Therefore, perioperative pain neuroscience education is proposed as a dramatic shift in educating patients prior to and following surgery for lumbar radiculopathy. Rather than focusing on the surgical procedure, ergonomics or lumbar biomechanics, perioperative pain neuroscience education teaches people about the underlying mechanisms of pain, including the pain they will feel following surgery. RESEARCH OBJECTIVES: The primary objective of the study is to examine whether perioperative pain neuroscience education ('brain school') is more effective than classic back school in reducing pain and improving pain inhibition in patients undergoing surgery for spinal radiculopathy. A secondary objective is to examine whether perioperative pain neuroscience education is more effective than classic back school in: reducing postoperative healthcare expenditure, improving functioning in daily life, increasing return to work, and improving surgical experience (ie, being better prepared for surgery, reducing incongruence between the expected and actual experience) in patients undergoing surgery for spinal radiculopathy. DESIGN: A multi-centre, two-arm (1:1) randomised, controlled trial with 2-year follow-up. PARTICIPANTS AND SETTING: People undergoing surgery for lumbar radiculopathy (n=86) in two Flemish hospitals (one tertiary care, university-based hospital and one regional, secondary care hospital) will be recruited for the study. INTERVENTION: All participants will receive usual preoperative and postoperative care related to the surgery for lumbar radiculopathy. The experimental group will also receive perioperative pain neuroscience education comprising one preoperative and one postoperative individual educational session plus an educational booklet. CONTROL: Participants in the control group will receive perioperative back school on top of usual preoperative and postoperative care, comprising one preoperative and one postoperative individual educational session plus an educational booklet. MEASUREMENTS: Self-reported pain and endogenous pain modulation (including measurements of simultaneous cortical activation via electroencephalography) will be the primary outcome measures. Secondary outcome measures will include daily functioning, return to work, postoperative healthcare utilisation and surgical experience/satisfaction. Psychological factors will be measured as possible treatment mediators. PROCEDURE: All assessments will take place in the week preceding surgery (baseline), and at 3 days and 6 weeks after surgery. Intermediate and long-term follow-up assessments will take place at 6, 12 and 24 months after surgery. ANALYSIS: All data analyses will be based on the intention-to-treat principle. Repeated measures AN(C)OVA analyses will be used to evaluate and compare treatment effects. Baseline data, treatment centre, age and gender will be included as covariates. Statistical, as well as clinically, significant differences will be evaluated and effect sizes will be determined. In addition, the numbers needed to treat will be calculated. DISCUSSION: This study will determine whether pain neuroscience education is worthwhile for patients undergoing surgery for lumbar radiculopathy. It is expected that participants who receive perioperative pain neuroscience education will report less pain and have improved endogenous pain modulation, lower postoperative healthcare costs and improved surgical experience. Lower pain and improved endogenous pain modulation after surgery may reduce the risk of developing postoperative chronic pain.

摘要

简介:尽管在疼痛神经科学方面取得了科学进展,但围手术期教育仍然倾向于坚持生物医学模式。例如,这可能包括解释手术过程或“腰背学校”(专注于腰椎生物力学和人体工程学的教育)。目前基于生物医学模式的围手术期教育策略不仅无效,甚至会增加脊柱手术患者的焦虑和恐惧。因此,建议在腰椎神经根病患者手术前后进行围手术期疼痛神经科学教育,以实现教育方式的重大转变。这种教育方式不再关注手术过程、人体工程学或腰椎生物力学,而是教导人们有关疼痛的潜在机制,包括他们在手术后会感到的疼痛。 研究目的:该研究的主要目的是检验围手术期疼痛神经科学教育(“脑校”)是否比经典的腰背学校更能有效减轻疼痛并改善腰椎神经根病患者术后的疼痛抑制。次要目的是检验围手术期疼痛神经科学教育是否比经典的腰背学校更能有效降低以下风险:术后医疗保健支出、改善日常生活功能、增加重返工作岗位的机会,以及改善手术体验(即更好地为手术做准备,减少预期和实际体验之间的不匹配),这适用于接受腰椎神经根病手术的患者。 设计:一项多中心、两臂(1:1)随机对照试验,随访时间为 2 年。 参与者和设置:将招募来自两家佛兰德医院(一家三级护理、大学附属医院和一家区域二级护理医院)的 86 名接受腰椎神经根病手术的患者参加该研究。 干预措施:所有参与者都将接受与腰椎神经根病手术相关的术前和术后常规护理。实验组还将接受围手术期疼痛神经科学教育,包括一次术前和一次术后的个人教育课程以及一本教育手册。 对照组:对照组的参与者将在接受常规术前和术后护理的基础上接受围手术期腰背学校教育,包括一次术前和一次术后的个人教育课程以及一本教育手册。 测量:自我报告的疼痛和内源性疼痛调节(包括通过脑电图测量同时的皮质激活)将是主要的结果测量指标。次要结果测量指标将包括日常功能、重返工作岗位、术后医疗保健利用情况和手术体验/满意度。心理因素将作为可能的治疗中介进行测量。 程序:所有评估都将在手术前一周(基线)进行,并在手术后 3 天和 6 周进行。中期和长期随访评估将在手术后 6、12 和 24 个月进行。 分析:所有数据分析都将基于意向治疗原则进行。重复测量 AN(C)OVA 分析将用于评估和比较治疗效果。基线数据、治疗中心、年龄和性别将被纳入协变量。将评估统计学和临床显著差异,并确定效应大小。此外,还将计算需要治疗的人数。 讨论:本研究将确定疼痛神经科学教育是否对接受腰椎神经根病手术的患者有益。预计接受围手术期疼痛神经科学教育的参与者报告的疼痛更少,内源性疼痛调节得到改善,术后医疗保健费用降低,手术体验改善。术后疼痛减轻和内源性疼痛调节改善可能降低术后慢性疼痛的风险。

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[2]
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[3]
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[4]
Proportion of clinical holistic responders in patients with persistent spinal pain syndrome type II treated by subthreshold spinal cord stimulation compared to best medical treatment: a study protocol for a multicentric randomised controlled trial (TRADITION).

Trials. 2023-2-20

[5]
Exploring Associations between Healthcare Use and Demographics, Pain and Pain Cognitions in People Scheduled for Surgery for Lumbar Radiculopathy: A Cross-Sectional Study.

J Clin Med. 2023-1-3

[6]
Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study.

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[7]
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[8]
[Effects of preoperative neurobiological education on postoperative outcome : A systematic review].

Schmerz. 2022-12

[9]
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[10]
Health-related quality of life deviations from population norms in patients with lumbar radiculopathy: associations with pain, pain cognitions, and endogenous nociceptive modulation.

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