Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.
Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.
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DOI：
10.1093/pm/pnad006
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发表时间：
2023-08-04
期刊：
影响因子：
3.1
通讯作者：
Hooten, William M.
中科院分区：
文献类型：
--
作者：
Wasan, Ajay D.;Edwards, Robert R.;Kraemer, Kevin L.;Jeong, Jong;Kenney, Megan;Luong, Kevin;Cornelius, Marise C.;Mickles, Caitlin;Dharmaraj, Bhagya;Sharif, Essa;Stoltenberg, Anita;Emerick, Trent;Karp, Jordan F.;Bair, Matt J.;George, Steven Z.;Hooten, William M.
患有慢性下腰痛（CLBP）和共病抑郁症或焦虑症的患者非常普遍。消极情绪（NA）是指消极思想，情绪和行为的组合。高NA的CLBP患者疼痛更严重，治疗结果更差，处方阿片类药物滥用更严重。SYNNAPTIC（SYNergizing Negative Affect & Pain Treatment In Chronic pain）是一种治疗慢性疼痛的方法。一项抗抑郁药、恐惧回避康复或两者联合治疗300例高NA CLBP患者的随机比较有效性研究。在抗抑郁药或仅康复治疗组中，SYNNAPTIC包括4个月后对无应答者进行重新随机化的适应性设计。在常规疼痛临床治疗环境中进行的多中心试验：疼痛诊所和物理和职业治疗治疗中心。入选标准包括伴有抑郁和焦虑症状升高的CLBP。抗疲劳和康复治疗遵循经验证的有效方案，用于高NA患者的肌肉骨骼疼痛。把握度和样本量基于一项纳入71例受试者的4组初步随机对照试验中这些相同治疗的联合治疗的上级结局。SYNNAPTIC解决了CLBP和高NA患者弱势亚组治疗缺乏循证方案的问题。我们假设，抗抑郁药联合恐惧回避康复治疗将比单独治疗更有效。 ClinicalTrials.gov ID：NCT04747314。
Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain). A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders. A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers. Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial. SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone. ClinicalTrials.gov ID: NCT04747314.
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