Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are useful for a variety of musculoskeletal injuries. It is not known whether topical NSAIDs should be used for patients presenting with acute nonradicular musculoskeletal low back pain. We conducted a randomized, placebo-controlled double-blind study in which patients 18 to 69 years of age visiting the emergency department (ED) with acute, nontraumatic, nonradicular, musculoskeletal low back pain were randomized at the time of discharge to treatment with 400 mg oral ibuprofen + placebo topical gel, 1% diclofenac topical gel + oral placebo, or 400 mg ibuprofen + 1% diclofenac topical gel. We measured outcomes using the Roland Morris Disability Questionnaire (RMDQ), a 24-item yes/no instrument about the effect of back pain on a respondent’s daily activities. The primary outcome was change in RMDQ score between ED discharge and 2 days later. Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms. In total, 3,281 patients were screened for participation, and 198 were randomized. Overall, 36% of the population were women, the mean age was 40 years (standard deviation, 13), and the median RMDQ score at baseline was 18 (25th to 75th percentile: 13 to 22), indicating substantial low back-related functional impairment. In total, 183 (92%) participants provided primary outcome data. Two days after the ED visit, the ibuprofen + placebo group had improved by 10.1 (95% confidence interval [CI] 7.5 to 12.7), the diclofenac gel + placebo group by 6.4 (95% CI 4.0 to 8.8), and the ibuprofen + diclofenac gel by 8.7 (95% CI 6.3 to 11.1). The between-group differences were as follows: ibuprofen versus diclofenac, 3.7 (95% CI 0.2 to 7.2); ibuprofen versus both medications 1.4 (95% CI −2.1 to 4.9); and diclofenac versus both medications, 2.3 (95% CI −5.7 to 1.0). Medication-related adverse events were reported by 3/60 (5%) ibuprofen patients, 1/63 (2%) diclofenac patients, and 4/64 (6%) patients who received both. Among patients with nontraumatic, nonradicular acute musculoskeletal low back pain discharged from an ED, topical diclofenac was probably less efficacious than oral ibuprofen. It demonstrated no additive benefit when coadministered with oral ibuprofen.

中文翻译：

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外用双氯芬酸与口服布洛芬与双氯芬酸 + 布洛芬治疗急诊科急性腰痛患者：一项随机研究

外用非甾体类抗炎药 (NSAID) 可用于治疗各种肌肉骨骼损伤。目前尚不清楚局部非甾体抗炎药是否应该用于患有急性非根性肌肉骨骼腰痛的患者。我们进行了一项随机、安慰剂对照双盲研究，其中 18 至 69 岁因急性、非创伤性、非根性、肌肉骨骼腰痛而到急诊科 (ED) 就诊的患者在出院时随机接受 400 名患者的治疗毫克口服布洛芬 + 安慰剂外用凝胶、1% 双氯芬酸外用凝胶 + 口服安慰剂，或 400 毫克布洛芬 + 1% 双氯芬酸外用凝胶。我们使用罗兰·莫里斯残疾问卷 (RMDQ) 来测量结果，这是一个包含 24 项是/否的工具，用于了解背痛对受访者日常活动的影响。主要结果是 ED 出院期间和 2 天后 RMDQ 评分的变化。通过询问研究药物是否引起任何新症状来引出与药物相关的不良事件。总共有 3,281 名患者接受了参与筛选，其中 198 名患者被随机分配。总体而言，36% 的人口为女性，平均年龄为 40 岁（标准差为 13），基线时的中位 RMDQ 评分为 18（第 25 至 75 个百分位数：13 至 22），表明存在大量与下背部相关的功能障碍。损害。总共 183 名 (92%) 参与者提供了主要结果数据。急诊科就诊两天后，布洛芬 + 安慰剂组改善了 10.1（95% 置信区间 [CI] 7.5 至 12.7），双氯芬酸凝胶 + 安慰剂组改善了 6.4（95% CI 4.0 至 8.8），布洛芬 +双氯芬酸凝胶 8.7（95% CI 6.3 至 11.1）。组间差异如下：布洛芬与双氯芬酸，3.7（95% CI 0.2 至 7.2）；布洛芬与两种药物相比 1.4（95% CI -2.1 至 4.9）；和双氯芬酸与两种药物相比，2.3（95% CI -5.7 至 1.0）。 3/60 (5%) 布洛芬患者、1/63 (2%) 双氯芬酸患者和 4/64 (6%) 接受两种药物治疗的患者报告了与药物相关的不良事件。对于从急诊科出院的非外伤性、非根治性急性肌肉骨骼腰痛患者，外用双氯芬酸可能不如口服布洛芬有效。当与口服布洛芬共同给药时，它没有表现出额外的益处。