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短切口与工具包微创腕管松解术治疗腕管综合征的前瞻性随机对照试验:评估前腕疼痛和恢复工作或活动时间。

Short incision versus minimally invasive surgery with tool-kit for carpal tunnel syndrome release: a prospective randomized control trial to evaluate the anterior wrist pain and time to return to work or activities.

机构信息

Department of Orthopaedics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

Clinical Epidemiology and Clinical Statistic Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

出版信息

BMC Musculoskelet Disord. 2022 Jul 25;23(1):708. doi: 10.1186/s12891-022-05663-5.

Abstract

TRIAL DESIGN

The prospective randomized controlled trial.

BACKGROUND

This study compares outcomes in terms of early postoperative anterior wrist pain and time to return to work or activities of daily living of patients who underwent carpal tunnel syndrome (CTS) release with short incision and those who had minimally invasive surgery (MIS) with CTS kits.

METHODS

A total of 24 patients diagnosed with primary CTS confirmed with electrodiagnosis at an academic university hospital were randomly assigned into one of two groups of 12 patients each: a short incision group and an MIS with tool-kit group using computer-generated block randomization (block of four). Sequentially numbered, opaque, sealed envelopes were used in the allocation concealment process. In the short incision group, skin was incised longitudinally from Kaplan's line to the area distal to transverse wrist crease (2.5-4.0 cm) while in the tool-kit group, an incision of less than 2.5 cm. was made using special MIS-CTS kits. Primary outcomes evaluated include visual analogue scale (VAS) measurement of pain intensity in the anterior carpal area both while at rest and while conducting daily activities at the 2nd week postoperatively as well as the time to return to activities of daily living and work. Improvement in the Michigan hand questionnaire (MHQ) score, a secondary outcome, was also measured at the 2nd week postoperatively. Patients, allocator and outcome assessor were blinded.

RESULTS

Demographic data, including preoperative electrodiagnostic severity and occupation, were similar in the two groups. There were no significant differences in terms of VAS of the early postoperative anterior carpal area at rest (p > 0.99), while conducting daily activities (p = 0.89) and time to return to activities of daily living (p = 0.46) and work (p = 0.24). The MHQ score improvement at the 2nd week postoperatively showed no significant difference between the groups (p = 0.95). The MIS wound length in the tool-kit group was significantly shorter than in the short incision group (1.95 vs 2.92 cm, p < 0.01).

CONCLUSIONS

There is no difference in early postoperative anterior wrist pain, time to return to work or to activities of daily living between the surgical techniques. Short incision is recommended for benefit in term of cost-effectiveness, while MIS with tool-kit could be preferred in patients who concerned in cosmetic appearance between the surgical techniques.

TRIAL REGISTRATION

www.

CLINICALTRIALS

in.th (TCTR20200530003). Registered 30 May 2020.

摘要

试验设计

前瞻性随机对照试验。

背景

本研究比较了经皮腕管松解术(short incision)与微创外科工具包(MIS with tool-kit)治疗腕管综合征(CTS)患者的早期术后腕前疼痛和恢复日常活动或工作时间的结果。

方法

在一家学术大学医院,共有 24 名经电诊断确诊为原发性 CTS 的患者被随机分配到两组,每组 12 名患者:short incision 组和 MIS with tool-kit 组。使用计算机生成的分组随机化(分组大小为 4)进行分组。在分配隐藏过程中使用了编号、不透明、密封的信封。在 short incision 组中,皮肤从 Kaplan 线纵向切开至腕横皱褶远端(2.5-4.0cm),而在工具包组中,使用特殊的 MIS-CTS 套件进行小于 2.5cm 的切口。主要结局评估包括术后第 2 周时腕前区域的静息和日常活动时的视觉模拟量表(VAS)疼痛强度,以及恢复日常活动和工作的时间。术后第 2 周还测量了密歇根手部问卷(MHQ)评分的改善情况,这是次要结局。患者、分配者和结局评估者均设盲。

结果

两组患者的人口统计学数据,包括术前电诊断严重程度和职业,均相似。两组术后早期腕前区域静息时的 VAS (p>0.99)、日常活动时的 VAS (p=0.89)和恢复日常活动及工作的时间(p=0.46)无显著差异。术后第 2 周时 MHQ 评分的改善两组间无显著差异(p=0.95)。工具包组 MIS 切口长度明显短于 short incision 组(1.95 对 2.92cm,p<0.01)。

结论

两种手术技术的术后早期腕前疼痛、恢复工作或日常生活活动的时间无差异。从成本效益的角度来看,short incision 是推荐的,而在关注手术美容外观的患者中,MIS with tool-kit 可能是首选。

试验注册

www.(TCTR20200530003)。2020 年 5 月 30 日注册。

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