群体认知行为疗法治疗初级保健中的下腰痛：一项随机对照试验和成本效益分析。

Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.

机构信息

Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.

出版信息

Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.

DOI:10.1016/S0140-6736(09)62164-4

PMID:20189241

Abstract

BACKGROUND

Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care.

METHODS

In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854.

FINDINGS

399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p<0.0001). The modified Von Korff pain score changed by 6.4% (3.14-9.66) and 13.4% (10.77-15.96), respectively (difference between groups 7.0%, 3.12-10.81; p<0.0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0.099; the incremental cost per QALY was 1786 pound sterling, and the probability of cost-effectiveness was greater than 90% at a threshold of 3000 pound sterling per QALY. There were no serious adverse events attributable to either treatment.

INTERPRETATION

Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider.

FUNDING

National Institute for Health Research Health Technology Assessment Programme.

摘要

背景

腰痛是一种常见且代价高昂的问题。我们评估了在初级保健中，对腰痛患者进行群体认知行为干预加最佳实践建议的效果。

方法

在这项在英格兰进行的务实、多中心、随机对照试验中，我们平行进行了成本效益分析，共招募了 56 家普通诊所的 701 名患有麻烦的亚急性或慢性腰痛的成年人，他们接受了积极的管理咨询。参与者通过计算机生成的分组随机分配，接受额外的评估和最多六次群体认知行为干预（n=468）或不接受进一步干预（对照组；n=233）。主要结局是在 12 个月时罗伦兹·莫里斯残疾问卷和改良冯·科勒夫残疾评分的基线变化。结果评估是盲法的，并遵循意向治疗原则，包括所有提供随访数据的随机参与者。本研究已注册，编号为 ISRCTN54717854。

结果

在 12 个月时，认知行为干预组有 399 名（85%）参与者和对照组有 199 名（85%）参与者纳入主要分析。参与者退出的最常见原因是不愿意完成问卷。在 12 个月时，对照组罗伦兹·莫里斯问卷评分的平均基线变化为 1.1 分（95%CI 0.39-1.72），认知行为干预组为 2.4 分（1.89-2.84）（两组间差异为 1.3 分，0.56-2.06；p=0.0008）。改良冯·科勒夫残疾评分分别变化 5.4%（1.99-8.90）和 13.8%（11.39-16.28）（两组间差异为 8.4%，4.47-12.32；p<0.0001）。改良冯·科勒夫疼痛评分分别变化 6.4%（3.14-9.66）和 13.4%（10.77-15.96）（两组间差异为 7.0%，3.12-10.81；p<0.0001）。认知行为干预获得的额外质量调整生命年（QALY）为 0.099；每增加一个 QALY 的增量成本为 1786 英镑，在 3000 英镑/QALY 的阈值下，成本效益的概率大于 90%。两种治疗均无严重不良事件。