A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis
A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis
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DOI：
10.1097/brs.0000000000000837
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发表时间：
2015-05-15
期刊：
影响因子：
3
通讯作者：
Dworkin, Robert H.
中科院分区：
文献类型：
--
作者：
Markman, John D.;Gewandter, Jennifer S.;Dworkin, Robert H.
研究设计.随机、双盲、安慰剂对照、单剂量交叉研究。目的：观察盐酸羟吗啡酮（OH）和丙氧芬/对乙酰氨基酚（PA）对腰椎管狭窄症伴神经源性跛行患者的镇痛效果。虽然阿片类药物经常用于神经源性跛行，但没有随机对照研究支持其对这种情况的疗效。神经源性跛行患者通常被排除在临床试验之外，或与非特异性慢性腰痛患者一起纳入，从而产生具有非常不同病理生理学和临床表现的异质性研究人群。参与者以随机顺序接受3种治疗中的每一种的单次给药。治疗间隔至少3天的洗脱期。主要结果变量是治疗给药后90分钟评估的至首次踏车行走诱导中度疼痛的时间（数字评定量表上>= 4/10）（T（firs）t）。次要结果指标包括患者对腰痛的总体评估、Roland-Morris残疾问卷、改良简明疼痛量表-简表、奥斯韦斯特里残疾指数和瑞士脊柱狭窄量表。由于PA从美国市场下架，该研究提前终止。24例患者接受了随机化; 21例完成了所有3个治疗阶段。治疗组之间在中位T-优先方面无显著差异（OH--安慰剂：中位数[98.3%置信限] = -0.25 min [-6.54，5.00]; PA--安慰剂：0.02 min [-7.65，4.90]; OH--PA：结论本试验未能证实OH或PA对神经源性跛行患者的益处。考虑到长期使用阿片类药物的潜在副作用，有必要进行额外的研究来评估持续阿片类药物治疗神经源性跛行的疗效。
Study Design. Randomized, double-blind, placebo-controlled, single-dose crossover study.Objective. To test the analgesic efficacy of oxymorphone hydrochloride (OH) and propoxyphene/acetaminophen (PA) for patients with neurogenic claudication associated with lumbar spinal stenosis.Summary of Background Data. Although opioids are often prescribed for neurogenic claudication, no randomized controlled studies support their efficacy for this condition. Patients with neurogenic claudication are generally excluded from clinical trials or included with patients who have nonspecific chronic low back pain, yielding a heterogeneous study population with very different pathophysiologies and clinical presentations.Methods. Participants received a single dose of each of the 3 treatments in random order. Treatments were separated by at least 3-day washout periods. The primary outcome variable was the time to first treadmill walking-induced moderate pain (>= 4 out of 10 on a Numeric Rating Scale) (T(firs)t) assessed 90 minutes after treatment administration. Secondary outcome measures included patient global assessment of low back pain, Roland-Morris Disability Questionnaire, Modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.Results. The study was prematurely terminated because of the removal of PA from the US market. Twenty-four patients were randomized; 21 completed all 3 treatment periods. There were no significant differences among the treatment groups with respect to the median T-first (OH--placebo: median [98.3% confidence limits] = -0.25 min [-6.54, 5.00]; PA--placebo: 0.02 min [-7.65, 4.90]; OH--PA: -0.27 min [-5.56, 6.66]).Conclusion This trial failed to demonstrate a benefit of OH or PA in patients experiencing neurogenic claudication. Considering the potential negative side effects of chronic opioid use, additional research is necessary to evaluate the efficacy of sustained opioid treatment specifically for neurogenic claudication.