Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481].
Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481].
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DOI：
10.1186/1471-2474-6-2
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发表时间：
2005-01-18
影响因子：
2.3
通讯作者：
Jarvik JG
中科院分区：
文献类型：
--
作者：
Martin BI;Levenson LM;Hollingworth W;Kliot M;Heagerty PJ;Turner JA;Jarvik JG
尽管有少量对照良好的研究且支持当前治疗方案的客观证据有限，但保守治疗仍然是治疗轻度至中度腕管综合征的标准治疗。人们越来越关注腕部磁共振成像在预测谁将从各种治疗中受益的有用性。将在 3 1/2 年内从神经外科、初级保健、电诊断诊所招募 200 名具有轻度至中度症状的患者。我们将排除具有去神经支配或大鱼际肌肉萎缩的临床或电诊断证据的患者。我们将随机分配患者接受明确的保守治疗方案或手术。保守护理治疗将包括手部治疗师就诊、锻炼、自我护理手册、工作调整/活动限制、B6 治疗、超声波和可能的类固醇注射。手术护理将由外科医生（内窥镜与开腹）进行，并进行常规和惯常的随访。所有患者将在基线时接受腕部 MRI 检查。我们将在随机分组后 3、6、9 和 12 个月联系患者，以完成腕管综合征评估问卷 (CTSAQ)。此外，我们还将比较 SF-36 II 版测量的残疾（活动和工作日损失）和总体健康状况。我们将控制人口统计数据并使用心理测量（SCL-90 躯体化和抑郁量表）以及 EDS 和 MRI 预测结果。我们设计了一项随机对照试验，将评估手术对轻度至中度腕管综合征患者的有效性。一个重要的次要目标是研究 MRI 预测患者结果的能力。
Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments. Two hundred patients with mild to moderate symptoms will be recruited over 3 1/2 years from neurological surgery, primary care, electrodiagnostic clinics. We will exclude patients with clinical or electrodiagnostic evidence of denervation or thenar muscle atrophy. We will randomly assign patients to either a well-defined conservative care protocol or surgery. The conservative care treatment will include visits with a hand therapist, exercises, a self-care booklet, work modification/ activity restriction, B6 therapy, ultrasound and possible steroid injections. The surgical care would be left up to the surgeon (endoscopic vs. open) with usual and customary follow-up. All patients will receive a wrist MRI at baseline. Patients will be contacted at 3, 6, 9 and 12 months after randomization to complete the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ). In addition, we will compare disability (activity and work days lost) and general well being as measured by the SF-36 version II. We will control for demographics and use psychological measures (SCL-90 somatization and depression scales) as well as EDS and MRI predictors of outcomes. We have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.
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影响因子：
9.9
作者：
Chang, MH;Chiang, HT;Lo, YK
通讯作者：
Lo, YK
影响因子：
1.9
作者：
Atroshi, I;Breidenbach, WC;McCabe, SJ
通讯作者：
McCabe, SJ
影响因子：
1.9
作者：
Campion, D
通讯作者：
Campion, D
影响因子：
7.1
作者：
ELLIS, J;FOLKERS, K;WOOD, FS
通讯作者：
WOOD, FS
影响因子：
10.5
作者：
DEROGATIS, LR;RICKELS, K;ROCK, AF
通讯作者：
ROCK, AF