Vanni Daniele, Sirabella Francesco Saverio, Galzio Renato, Salini Vincenzo, Magliani Vincenzo
Orthopaedic and Traumatology Department, "G. D'Annunzio" University, Chieti;
Neurosurgery Department, "L'Aquila" University, L'Aquila; and.
J Neurosurg. 2015 Nov;123(5):1230-7. doi: 10.3171/2014.11.JNS14901. Epub 2015 May 29.
The purpose of this study was to assess the effectiveness and safety of an alternative minimally invasive technique for the treatment of carpal tunnel syndrome (CTS).
This was designed as a prospective, randomized, open-label, blinded end point evaluation (PROBE) study. The active comparison was double tunnels technique (DTT) (Group A, 110 patients) versus standard open decompression of the median nerve (control [Group B], 110 patients). Patient recruitment started in January 2011. The primary outcomes were the functional Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) scores and visual analog scale (VAS) scores for pain (pVAS) at Weeks 2 and 4, and at Months 3, 6, and 12. The secondary outcome was the aesthetics (aVAS) score at Weeks 2 and 4, and at Months 3, 6, and 12.
The Student t-test and ANOVA were used, and the results were considered statistically significant if the p value was ≤0.05 for continuous variables. The DTT is a tissue-sparing approach that allows the surgeon to limit the length of the incision (0.6±0.05 cm) and to respect the palmar fascia and the subcutaneous tissue. Recovery from wrist pain, night pain, numbness, stiffness, and weakness was achieved more effectively and quickly compared with the standard approach. Better BCTSQ, pVAS, and aVAS scores were observed in Group A.
The DTT is a safe and effective approach for the treatment of CTS. This technique entails faster recovery times, better aesthetic outcomes, and lower risks of complications.
本研究旨在评估一种用于治疗腕管综合征(CTS)的替代性微创技术的有效性和安全性。
本研究设计为一项前瞻性、随机、开放标签、盲终点评估(PROBE)研究。主动对照为双隧道技术(DTT)(A组,110例患者)与正中神经标准开放减压术(对照组[B组],110例患者)。患者招募于2011年1月开始。主要结局指标为第2周和第4周以及第3、6和12个月时的功能性波士顿腕管综合征问卷(BCTSQ)评分和疼痛视觉模拟量表(VAS)评分(pVAS)。次要结局指标为第2周和第4周以及第3、6和12个月时的美观度(aVAS)评分。
采用Student t检验和方差分析,对于连续变量,若p值≤0.05,则结果被认为具有统计学意义。DTT是一种保留组织的方法,可使外科医生限制切口长度(0.6±0.05 cm)并保留掌腱膜和皮下组织。与标准方法相比,腕部疼痛、夜间疼痛、麻木、僵硬和无力的恢复更有效且更快。A组的BCTSQ、pVAS和aVAS评分更高。
DTT是一种治疗CTS的安全有效的方法。该技术恢复时间更快、美观效果更好且并发症风险更低。