Jarvik Jeffrey G, Comstock Bryan A, Kliot Michel, Turner Judith A, Chan Leighton, Heagerty Patrick J, Hollingworth William, Kerrigan Carolyn L, Deyo Richard A
Department of Radiology, School of Medicine, University of Washington, Seattle, WA, USA.
Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
A previous randomised controlled trial reported greater efficacy of surgery than of splinting for patients with carpal tunnel syndrome. Our aim was to compare surgical versus multi-modality, non-surgical treatment for patients with carpal tunnel syndrome without denervation. We hypothesised that surgery would result in improved functional and symptom outcomes.
In this parallel-group randomised controlled trial, we randomly assigned 116 patients from eight academic and private practice centres, using computer-generated random allocation stratified by site, to carpal tunnel surgery (n=57) or to a well-defined, non-surgical treatment (including hand therapy and ultrasound; n=59). The primary outcome was hand function measured by the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ) at 12 months assessed by research personnel unaware of group assignment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00032227.
44 (77%) patients assigned to surgery underwent surgery. At 12 months, 101 (87%) completed follow-up and were analysed (49 of 57 assigned to surgery and 52 of 59 assigned to non-surgical treatment). Analyses showed a significant 12-month adjusted advantage for surgery in function (CTSAQ function score: Delta -0.40, 95% CI 0.11-0.70, p=0.0081) and symptoms (CTSAQ symptom score: 0.34, 0.02-0.65, p=0.0357). There were no clinically important adverse events and no surgical complications.
Symptoms in both groups improved, but surgical treatment led to better outcome than did non-surgical treatment. However, the clinical relevance of this difference was modest. Overall, our study confirms that surgery is useful for patients with carpal tunnel syndrome without denervation.
NIH/NIAMS 5P60AR048093 and the Intramural Research Program of the NIH Clinical Center.
一项先前的随机对照试验报告称，对于腕管综合征患者，手术治疗比夹板固定治疗更有效。我们的目的是比较手术治疗与多模式非手术治疗对无神经损伤的腕管综合征患者的效果。我们假设手术治疗会改善功能和症状结局。
在这项平行组随机对照试验中，我们从8个学术和私人诊所中心随机分配了116名患者，采用计算机生成的随机分配方法，按地点分层，分为腕管手术组（n = 57）或明确的非手术治疗组（包括手部治疗和超声治疗；n = 59）。主要结局是在12个月时由不知道分组情况的研究人员通过腕管综合征评估问卷（CTSAQ）测量的手部功能。分析采用意向性分析。该试验已在ClinicalTrials.gov注册，编号为NCT00032227。
分配到手术组的44名（77%）患者接受了手术。在12个月时，101名（87%）患者完成随访并进行了分析（分配到手术组的57名患者中有49名，分配到非手术治疗组的59名患者中有52名）。分析显示，手术治疗在功能（CTSAQ功能评分：差值 -0.40，95%CI 0.11 - 0.70，p = 0.0081）和症状（CTSAQ症状评分：0.34，0.02 - 0.65，p = 0.0357）方面在12个月时有显著的调整优势。没有具有临床重要意义的不良事件，也没有手术并发症。
两组症状均有改善，但手术治疗比非手术治疗的结局更好。然而，这种差异的临床相关性较小。总体而言，我们的研究证实手术治疗对无神经损伤的腕管综合征患者有用。
美国国立卫生研究院/国立关节炎、肌肉骨骼和皮肤疾病研究所5P60AR048093以及美国国立卫生研究院临床中心的内部研究项目。
