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一项关于椎间盘退变引起的背痛手术治疗的前瞻性队列研究;研究方案。

A prospective cohort study of surgical treatment for back pain with degenerated discs; study protocol.

作者信息

Deyo Richard A, Mirza Sohail K, Heagerty Patrick J, Turner Judith A, Martin Brook I

机构信息

Department of Medicine, Seattle, Washington 98104, USA.

出版信息

BMC Musculoskelet Disord. 2005 May 24;6:24. doi: 10.1186/1471-2474-6-24.

Abstract

BACKGROUND

The diagnosis of discogenic back pain often leads to spinal fusion surgery and may partly explain the recent rapid increase in lumbar fusion operations in the United States. Little is known about how patients undergoing lumbar fusion compare in preoperative physical and psychological function to patients who have degenerative discs, but receive only non-surgical care.

METHODS

Our group is implementing a multi-center prospective cohort study to compare patients with presumed discogenic pain who undergo lumbar fusion with those who have non-surgical care. We identify patients with predominant low back pain lasting at least six months, one or two-level disc degeneration confirmed by imaging, and a normal neurological exam. Patients are classified as surgical or non-surgical based on the treatment they receive during the six months following study enrollment.

RESULTS

Three hundred patients discogenic low back pain will be followed in a prospective cohort study for two years. The primary outcome measure is the Modified Roland-Morris Disability Questionnaire at 24-months. We also evaluate several other dimensions of outcome, including pain, functional status, psychological distress, general well-being, and role disability.

CONCLUSION

The primary aim of this prospective cohort study is to better define the outcomes of lumbar fusion for discogenic back pain as it is practiced in the United States. We additionally aim to identify characteristics that result in better patient selection for surgery. Potential predictors include demographics, work and disability compensation status, initial symptom severity and duration, imaging results, functional status, and psychological distress.

摘要

背景

椎间盘源性腰痛的诊断常常导致脊柱融合手术,这可能部分解释了美国近期腰椎融合手术快速增加的现象。对于接受腰椎融合手术的患者与患有椎间盘退变但仅接受非手术治疗的患者在术前身体和心理功能方面的比较,我们了解甚少。

方法

我们的团队正在开展一项多中心前瞻性队列研究,以比较接受腰椎融合手术的疑似椎间盘源性疼痛患者与接受非手术治疗的患者。我们纳入持续至少六个月的以腰痛为主、经影像学证实有一或两个节段椎间盘退变且神经学检查正常的患者。根据患者在研究入组后六个月内接受的治疗,将其分为手术组或非手术组。

结果

三百例椎间盘源性腰痛患者将在一项前瞻性队列研究中随访两年。主要结局指标是24个月时的改良罗兰-莫里斯功能障碍问卷。我们还评估结局的其他几个维度,包括疼痛、功能状态、心理困扰、总体幸福感和角色功能障碍。

结论

这项前瞻性队列研究的主要目的是更好地明确美国实施的针对椎间盘源性腰痛的腰椎融合手术的结局。我们还旨在确定有助于更好地选择手术患者的特征。潜在预测因素包括人口统计学特征、工作和残疾补偿状况、初始症状严重程度和持续时间、影像学结果、功能状态和心理困扰。

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