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首次椎间盘手术后行为分级活动与常规护理的比较:一项随机临床试验设计的考量

Behavioral-graded activity compared with usual care after first-time disk surgery: considerations of the design of a randomized clinical trial.

作者信息

Ostelo R W, Köke A J, Beurskens A J, de Vet H C, Kerckhoffs M R, Vlaeyen J W, Wolters P M, Berfelo M W, van den Brandt P A

机构信息

Department of Epidemiology, Maastricht University, The Netherlands.

出版信息

J Manipulative Physiol Ther. 2000 Jun;23(5):312-9.

PMID:10863250
Abstract

OBJECTIVE

To present the design of a trial on the effectiveness of a behavioral-graded activity model.

DESIGN

Randomized clinical trial.

PATIENTS

Patients undergoing first-time lumbar disk surgery who still have low-back pain at the 6-week neurosurgical consultation.

INTERVENTIONS

A patient-tailored behavioral-graded activity program that is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent.

OUTCOME MEASURES

Primary measures are the patient's global impression of the effect and their functional status. Secondary measures are kinesiophobia, catastrophizing, pain, main complaint, range of motion, and relapses. The direct and indirect costs will also be assessed. The effect measures are rated before randomization and 3, 6, and 12 months later.

DISCUSSION

Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.

摘要

目的

介绍一项关于行为分级活动模型有效性的试验设计。

设计

随机临床试验。

患者

首次接受腰椎间盘手术且在神经外科6周会诊时仍有腰痛的患者。

干预措施

基于操作性疗法的针对患者量身定制的行为分级活动方案。该方案的关键要素包括基线测量、目标设定和时间应急。将该方案与物理治疗中的常规护理(以疼痛为条件)进行比较。

结局指标

主要指标为患者对疗效的总体印象及其功能状态。次要指标为运动恐惧、灾难化思维、疼痛、主要症状、活动范围和复发情况。还将评估直接和间接成本。在随机分组前以及3、6和12个月后对疗效指标进行评分。

讨论

已经进行了多项关于行为治疗有效性的试验。受试者均为慢性腰痛患者。在本试验中,我们在初级保健环境中对首次椎间盘手术后的患者应用这种治疗方法。

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