Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Medical College, Albert Einstein College of Medicine, Bronx, New York.
JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination.
To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, 3-group study was conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014.
All participants were given 20 tablets of naproxen, 500 mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5 mg; or oxycodone, 5 mg/acetaminophen, 325 mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge.
The primary outcome was improvement in RMDQ between ED discharge and 1 week later.
Demographic characteristics were comparable among the 3 groups. At baseline, median RMDQ score in the placebo group was 20 (interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20 (IQR,17-22). At 1-week follow-up, the mean RMDQ improvement was 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 (98.3% CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3% CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine, 0.9 (98.3% CI, -2.1 to 3.9; P = .45).
Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.
clinicaltrials.gov Identifier: NCT01587274.
下腰痛（LBP）每年导致超过 250 万次美国急诊部（ED）就诊。这些患者通常接受非甾体抗炎药、对乙酰氨基酚、阿片类药物或骨骼肌松弛剂治疗，通常联合使用。
比较急性 LBP 患者在 ED 就诊后 1 周和 3 个月时的功能结局和疼痛，这些患者随机分为 10 天疗程的 1 组（1）萘普生+安慰剂；（2）萘普生+环苯扎林；或（3）萘普生+羟考酮/对乙酰氨基酚。
设计、地点和参与者：这项随机、双盲、3 组研究在纽约市布朗克斯的一家城市 ED 进行。如果患者在 ED 出院时有罗伦兹-莫里斯残疾问卷（RMDQ）评分大于 5，则有资格入选。RMDQ 是一种常用的 24 项问卷，用于测量 LBP 和相关的功能障碍，其中 0 表示没有功能障碍，24 表示最大障碍。从 2012 年 4 月开始，共接触了 2588 名患者进行登记。在 323 名被认为有参与资格的患者中，有 107 名被随机分配接受安慰剂，108 名接受环苯扎林，108 名接受羟考酮/对乙酰氨基酚。随访于 2014 年 12 月完成。
所有参与者均给予萘普生 20 片，500mg，每日两次服用。他们被随机分配接受安慰剂 60 片；环苯扎林，5mg；或羟考酮，5mg/对乙酰氨基酚，325mg。参与者被指示根据需要每 8 小时服用 1 或 2 片，以缓解 LBP。他们还在出院前接受了 10 分钟的标准化 LBP 教育课程。
主要结果是 ED 出院后和 1 周后 RMDQ 的改善。
3 组的人口统计学特征相似。在基线时，安慰剂组的中位数 RMDQ 评分为 20（四分位距[IQR]，17-21），环苯扎林组为 19（IQR，17-21），羟考酮/对乙酰氨基酚组为 20（IQR，17-22）。在 1 周随访时，安慰剂组的平均 RMDQ 改善为 9.8，环苯扎林组为 10.1，羟考酮/对乙酰氨基酚组为 11.1。与安慰剂相比，环苯扎林组的平均 RMDQ 改善差异为 0.3（98.3% CI，-2.6 至 3.2；P=0.77），羟考酮/对乙酰氨基酚组为 1.3（98.3% CI，-1.5 至 4.1；P=0.28），羟考酮/对乙酰氨基酚组为 0.9（98.3% CI，-2.1 至 3.9；P=0.45）。
在因急性、非创伤性、非神经根性 LBP 就诊 ED 的患者中，在萘普生单独治疗的基础上加用环苯扎林或羟考酮/对乙酰氨基酚并不能改善 1 周时的功能结局或疼痛。这些发现不支持在这种情况下使用这些额外的药物。
clinicaltrials.gov 标识符：NCT01587274。
