Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain A Randomized Clinical Trial
Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain A Randomized Clinical Trial
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DOI：
10.1001/jamaneurol.2018.3376
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发表时间：
2019-02-01
期刊：
影响因子：
29
通讯作者：
McAuley, James H.
中科院分区：
文献类型：
--
作者：
Traeger, Adrian C.;Lee, Hopin;McAuley, James H.
许多急性腰痛患者不能通过基本的一线护理（建议，安慰和简单的镇痛，如果必要的话）恢复。目前尚不清楚强化患者教育是否改善了那些已经接受一线护理的患者的临床结局。目的确定强化患者教育对急性腰痛患者的有效性。设计、设置和参与者这项随机、安慰剂对照的临床试验从全科诊所、理疗诊所和澳大利亚悉尼的一个研究中心招募了患者，于9月10日至12月30日在澳大利亚悉尼的一个研究中心进行。2013年和2015年12月2日。试验随访于2016年12月17日完成。初级保健医生邀请了618名急性腰痛患者参加。研究人员排除了416名潜在参与者。所有202名合格参与者的腰痛持续时间均少于6周，并且根据预测慢性疼痛起始（PICKUP）工具（一种经验证的预后模型），患慢性腰痛的风险很高。参与者被随机分配在1：1的比例，无论是病人的教育或安慰剂patient education.INTERVENTIONS所有的参与者接受建议的一线护理急性腰痛从他们通常的医生。参与者接受额外的2 x 1小时的患者教育（疼痛和生物心理社会贡献者的信息加上自我管理技术，如保持活跃和起搏）或安慰剂患者教育（积极倾听，没有信息或建议）。次要结果包括残疾（24分罗兰莫里斯残疾问卷）在1周，并在3，6，12 months. Results的202名参与者随机试验，平均（SD）参与者的年龄为45（14.5）岁，103（51.0%）是女性。所有时间点的保留率均大于90%。在降低疼痛强度方面，强化患者教育并不比安慰剂患者教育更有效（3个月平均[SD]疼痛强度：2.1 [2.4] vs 2.4 [2.2]; 3个月时的平均差异，-0.3 [95% CI，-1.0至0.3]）。强化患者教育对第1周残疾的次要结局有微小影响（平均差异，24分量表上为-1.6分[95% CI，-3.1至-0.1]）和3个月（平均差异，-1.7分，[95% CI，-3.2至-0.2]），但在6个月或12个月时没有。对急性腰痛患者的线上护理并不能改善疼痛结果。临床指南建议为急性腰痛高危患者提供复杂和密集的支持可能为时过早。
IMPORTANCE Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care.OBJECTIVE To determine the effectiveness of intensive patient education for patients with acute low back pain.DESIGN, SETTING, AND PARTICIPANTS This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks' duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1: 1 ratio to either patient education or placebo patient education.INTERVENTIONS All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 x 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice).MAIN OUTCOMES AND MEASURES The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months.RESULTS Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, -0.3 [95% CI, -1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, -1.6 points on a 24-point scale [95% CI, -3.1 to -0.1]) and 3 months (mean difference, -1.7 points, [95% CI, -3.2 to -0.2]) but not at 6 or 12 months.CONCLUSIONS AND RELEVANCE Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature.