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经皮类固醇注射治疗坐骨神经痛患者结局的预测因素:POiSE 前瞻性观察队列研究方案。

Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol.

机构信息

School of Medicine, Keele University, Keele, Staffordshire, UK

North Staffordshire and Stoke on Trent Integrated Musculoskeletal Service, Midlands Partnership University NHS Foundation Trust, Staffordshire, UK.

出版信息

BMJ Open. 2023 Nov 19;13(11):e077776. doi: 10.1136/bmjopen-2023-077776.

Abstract

INTRODUCTION

Sciatica can be very painful and, in most cases, is due to pressure on a spinal nerve root from a disc herniation with associated inflammation. For some patients, the pain persists, and one management option is a spinal epidural steroid injection (ESI). The aim of an ESI is to relieve leg pain, improve function and reduce the need for surgery. ESIs work well in some patients but not in others, but we cannot identify these patient subgroups currently. This study aims to identify factors, including patient characteristics, clinical examination and imaging findings, that help in predicting who does well and who does not after an ESI. The overall objective is to develop a prognostic model to support individualised patient and clinical decision-making regarding ESI.

METHODS

POiSE is a prospective cohort study of 439 patients with sciatica referred by their clinician for an ESI. Participants will receive weekly text messages until 12 weeks following their ESIand then again at 24 weeks following their ESI to collect data on leg pain severity. Questionnaires will be sent to participants at baseline, 6, 12 and 24 weeks after their ESI to collect data on pain, disability, recovery and additional interventions. The prognosis for the cohort will be described. The primary outcome measure for the prognostic model is leg pain at 6 weeks. Prognostic models will also be developed for secondary outcomes of disability and recovery at 6 weeks and additional interventions at 24 weeks following ESI. Statistical analyses will include multivariable linear and logistic regression with mixed effects model.

ETHICS AND DISSEMINATION

The POiSE study has received ethical approval (South Central Berkshire B Research Ethics Committee 21/SC/0257). Dissemination will be guided by our patient and public engagement group and will include scientific publications, conference presentations and social media.

摘要

简介

坐骨神经痛可能非常疼痛,在大多数情况下,是由于椎间盘突出症引起的神经根受压,并伴有炎症。对于一些患者,疼痛持续存在,一种治疗选择是脊柱硬膜外类固醇注射(ESI)。ESI 的目的是缓解腿部疼痛、改善功能并减少手术需求。ESI 在一些患者中效果很好,但在另一些患者中效果不佳,但我们目前无法确定这些患者亚组。本研究旨在确定有助于预测 ESI 后哪些患者效果良好而哪些患者效果不佳的因素,包括患者特征、临床检查和影像学发现。总体目标是开发一种预测模型,以支持针对 ESI 的个体化患者和临床决策。

方法

POiSE 是一项针对 439 名坐骨神经痛患者的前瞻性队列研究,这些患者由其临床医生转诊接受 ESI。参与者将在 ESI 后每周接受短信,直到 12 周后,然后在 ESI 后 24 周再次接受短信,以收集腿部疼痛严重程度的数据。基线、6、12 和 24 周后将向参与者发送问卷,以收集疼痛、残疾、恢复和额外干预的数据。将描述队列的预后。预测模型的主要结局测量指标是 ESI 后 6 周的腿部疼痛。还将为 ESI 后 6 周的残疾和恢复的次要结局以及 24 周的额外干预措施开发预测模型。统计分析将包括混合效应模型的多变量线性和逻辑回归。

伦理和传播

POiSE 研究已获得伦理批准(南中伯克希尔 B 研究伦理委员会 21/SC/0257)。传播将由我们的患者和公众参与小组指导,并将包括科学出版物、会议演讲和社交媒体。

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