A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain
A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain
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DOI：
10.1097/j.pain.0000000000001834
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发表时间：
2020-06-01
期刊：
影响因子：
7.4
通讯作者：
Rutledge, Thomas
中科院分区：
文献类型：
--
作者：
Gould, Hilary M.;Atkinson, Joseph Hampton;Rutledge, Thomas
本临床试验评价了三环类抗抑郁药（地昔帕明）和认知行为疗法（CBT）相对于活性安慰剂治疗对慢性背痛的独立和联合作用。参与者（n = 142）是每天经历强度>= 4/10的慢性背痛的患者，他们被随机分配到单中心、双盲、12周、4臂、平行组对照临床试验，（1）滴定低浓度地昔帕明以达到15至65 ng/mL的血清浓度水平;（2）CBT和活性安慰剂药物（甲磺酸苯扎托品，0.125 mg）;（3）低浓度地昔帕明和CBT;（4）活性苯扎托品安慰剂药物。参与者在治疗前后完成了差异描述量表和罗兰莫里斯残疾量表，分别作为背痛强度和残疾结局的有效指标。每种情况下的参与者从治疗前到治疗后疼痛强度显着降低（平均变化范围为-2.58至3.87，Cohen's d = 0.46-0.84），疼痛残疾改善（平均变化= -3.04至4.29，Cohen's d = 0.54-0.88）。然而，治疗后的意向治疗分析显示，任何条件之间均无显著差异，效应量范围为0.06至0.27。这项临床试验的结果不支持地昔帕明、CBT或其组合在减少慢性背痛强度或残疾方面在统计学上上级活性药物安慰剂的假设。主要限制包括招募计划样本量的71%和使用多个入选/排除标准，这可能限制了对更广泛的慢性背痛患者人群的普遍性。
This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of >= 4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain.