Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Feasibility Randomized Controlled Trial.
Combining Procedural and Behavioral Treatments for Chronic Low Back Pain: A Pilot Feasibility Randomized Controlled Trial.
复制标题
结合程序和行为治疗慢性腰痛：试点可行性随机对照试验。
DOI：
10.1101/2023.06.02.23290392
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Suri,Pradeep
中科院分区：
文献类型：
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作者：
Tanus,AdrienneD;Nishio,Isuta;Williams,Rhonda;Friedly,Janna;Soares,Bosco;Anderson,Derek;Bambara,Jennifer;Dawson,Timothy;Hsu,Amy;Kim,PeggyY;Krashin,Daniel;Piero,LarissaDel;Korpak,Anna;Timmons,Andrew;Suri,Pradeep
慢性下腰痛（CLBP）的个体化治疗效果很小.目的：（1）评价对这些治疗方法进行析因随机对照试验的可行性;和（2）估计（a）背支内侧分支神经的腰椎射频消融（LRFA）的单独和组合治疗效果（与模拟LRFA控制程序相比）和（B）CLBP活动跟踪器-知情视频支持认知行为治疗程序在一项2 × 2析因随机对照试验中，参与者（n= 13）以1：1：1：1的比例随机分组。可行性目标包括入组比例≥ 30%，随机化比例≥ 80%，完成3个月罗兰-莫里斯残疾问卷（RMDQ）主要结局终点的随机化受试者比例≥ 80%。意向治疗分析used.ResultsThe入组比例为62%，随机化比例为81%，所有随机参与者完成了主要结局。尽管无统计学显著性，但LRFA与对照组相比对3个月RMDQ有有益的中度影响（-3.25 RMDQ点[95%置信区间[CI]，-10.18至3.67]）。与对照组相比，Active-CBT具有显著的、有益的、大幅度的效应（−6.29 [95% CI，−10.97至−1.60]）。虽然没有统计学显著性，有一个有益的，大的效果LRFA+活性CBT与对照组（−8.37 [95%CI：−21.47，4.74]）.ConclusionWe得出结论，这是可行的进行一项随机对照试验相结合的程序和行为治疗CLBP.ClinicalTrials.gov注册：https://clinicaltrials.gov/ct2/show/NCT03520387。
BackgroundIndividual treatments for chronic low back pain (CLBP) have small magnitude effects. Combining different types of treatments may produce larger effects.ObjectiveTo (1) assess feasibility of conducting a factorial randomized controlled trial of these treatments; and (2) estimate individual and combined treatment effects of (a) lumbar radiofrequency ablation (LRFA) of the dorsal ramus medial branch nerves (vs. a simulated LRFA control procedure) and (b) Activity Tracker‐Informed Video‐Enabled Cognitive Behavioral Therapy program for CLBP (AcTIVE‐CBT) (vs. an educational control treatment) on back‐related disability at 3 months post‐randomization.MethodsParticipants (n= 13) were randomized in a 1:1:1:1 ratio in a 2 × 2 factorial randomized controlled trial. Feasibility goals included an enrollment proportion ≥ 30%, a randomization proportion ≥ 80%, and a ≥ 80% proportion of randomized participants completing the 3‐month Roland‐Morris Disability Questionnaire (RMDQ) primary outcome end point. An intent‐to‐treat analysis was used.ResultsThe enrollment proportion was 62%, the randomization proportion was 81%, and all randomized participants completed the primary outcome. Though not statistically significant, there was a beneficial, moderate‐magnitude effect of LRFA versus control on 3‐month RMDQ (−3.25 RMDQ points [95% confidence interval [CI], −10.18 to 3.67]). There was a significant, beneficial, large‐magnitude effect of AcTIVE‐CBT versus control (−6.29 [95% CI, −10.97 to −1.60]). Though not statistically significant, there was a beneficial, large effect of LRFA+AcTIVE‐CBT versus control (−8.37 [95% CI: −21.47, 4.74]).ConclusionWe conclude that it is feasible to conduct a randomized controlled trial combining procedural and behavioral treatments for CLBP.ClinicalTrials.gov Registration: https://clinicaltrials.gov/ct2/show/NCT03520387.