Neuroscience Research Australia, Sydney, New South Wales, Australia.
Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
JAMA Neurol. 2019 Feb 1;76(2):161-169. doi: 10.1001/jamaneurol.2018.3376.
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 × 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. TRIAL REGISTRATION: Australian Clinical Trial Registration Number: 12612001180808.
重要性:许多急性腰痛患者在接受基本一线治疗(建议、安慰和简单镇痛,如果需要)后无法康复。目前尚不清楚强化患者教育是否能改善已经接受一线治疗的患者的临床结局。 目的:确定强化患者教育对急性腰痛患者的有效性。 设计、地点和参与者:这是一项随机、安慰剂对照的临床试验,参与者来自澳大利亚悉尼的普通诊所、物理治疗诊所和研究中心,招募时间为 2013 年 9 月 10 日至 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 名符合条件的参与者都有少于 6 周的腰痛病史,根据预测慢性腰痛发作(PICKUP)工具,这是一种经过验证的预后模型,他们有发展为慢性腰痛的高风险。参与者按照 1:1 的比例随机分配接受患者教育或安慰剂患者教育。 干预措施:所有参与者都接受了来自其常规医生的急性腰痛一线治疗建议。参与者接受了另外 2 次 1 小时的患者教育(关于疼痛和生物心理社会因素的信息,以及自我管理技术,如保持活动和控制节奏)或安慰剂患者教育(积极倾听,没有信息或建议)。 主要结果和测量:主要结局是 3 个月时的疼痛强度(11 分数字评定量表)。次要结局包括 1 周、3 个月、6 个月和 12 个月时的残疾(24 分 Roland Morris 残疾问卷)。 结果:在 202 名随机参加试验的参与者中,参与者的平均(SD)年龄为 45(14.5)岁,103 名(51.0%)为女性。所有时间点的保留率均大于 90%。强化患者教育在减轻疼痛强度方面并不优于安慰剂患者教育(3 个月时的平均(SD)疼痛强度:2.1[2.4]与 2.4[2.2];3 个月时的平均差异,-0.3[95%置信区间,-1.0 至 0.3])。强化患者教育对残疾的次要结局有一定的影响,在 1 周(平均差异,-1.6 分[24 分量表] [95%置信区间,-3.1 至 -0.1])和 3 个月(平均差异,-1.7 分[95%置信区间,-3.2 至 -0.2])时,但在 6 个月和 12 个月时没有。 结论和相关性:在急性腰痛患者的一线治疗中增加 2 小时的患者教育并不能改善疼痛结局。向有急性腰痛高风险的患者提供复杂和强化支持的临床指南建议可能为时过早。 试验注册:澳大利亚临床试验注册编号:12612001180808。
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