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靶向留置导管与手法治疗相结合的骶管硬膜外类固醇注射治疗腰椎间盘突出症和神经根病患者的疗效:一项前瞻性、随机、单盲对照试验

Efficacy of Caudal Epidural Steroid Injection with Targeted Indwelling Catheter and Manipulation in Managing Patients with Lumbar Disk Herniation and Radiculopathy: A Prospective, Randomized, Single-Blind Controlled Trial.

作者信息

Yin Mengchen, Mo Wen, Wu Haiyang, Xu Jinhai, Ye Jie, Chen Ni, Marla Anastasia Sulindro, Ma Junming

机构信息

Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Orthopaedics, Central Hospital of Huangpu District, Shanghai, China.

出版信息

World Neurosurg. 2018 Jun;114:e29-e34. doi: 10.1016/j.wneu.2018.01.162. Epub 2018 Feb 2.

DOI:10.1016/j.wneu.2018.01.162
PMID:29410375
Abstract

BACKGROUND

Lumbar disk herniation (LDH) is considered a common cause of lumbosacral radiculopathy. Epidural steroid injection is a common method to treat inflammation associated with low back-related leg pain. Spinal manipulations are widely used, and systematic reviews have also shown that these manipulations are more effective than placebos.

OBJECTIVE

Due to the absence of clinical evidence, we designed a prospective, randomized, single-blind controlled trial in patients with LDH with radiculopathy, aiming to detect the safety and clinical efficacy of targeted indwelling catheter combined with "4-step" manipulative therapy in patients with LDH.

METHODS

Patient visits were performed at baseline and days 1, 3, 7, and 28 after treatment. Clinical outcomes were measured using visual analog scale for back and leg pain, Oswestry Disability Index (ODI), and clinical symptom scores of the Japanese Orthopedic Association (JAO).

RESULTS

The study included 85 eligible patients. They were categorized with a randomization schedule into a Catheter Group (N = 43) and No-Catheter Group (N = 42). Between the measurement points, there was a statistically significant difference in the visual analog scale (back) at days 1, 3, and 7 of follow-up after treatment between the 2 groups. The change was statistically different at days 1 and 3, and a higher change was observed in the Catheter Group compared with the No-Catheter Group. There was a statistically significant difference in change of JOA and ODI scores at day 1 of follow-up after treatment between the 2 groups, and a greater change was seen in the Catheter Group at days 1 and 3 compared with the No-Catheter Group.

LIMITATIONS

The small sample size was small, and the follow-up time was short. The study also lacked documents of adjuvant therapies, like individual patient exercise routines and analgesic drug therapy.

CONCLUSION

Both methods were effective in reducing pain intensity and functional disability compared with pretreatment. The Catheter Group showed a more significant decrease in visual analog scale and greater changes in JOA and ODI scores of short/term follow-up, compared with the No-Catheter Group. The therapy project was safe.

摘要

背景

腰椎间盘突出症(LDH)被认为是腰骶神经根病的常见病因。硬膜外类固醇注射是治疗与腰腿痛相关炎症的常用方法。脊柱推拿被广泛应用,系统评价也表明这些推拿比安慰剂更有效。

目的

由于缺乏临床证据,我们设计了一项针对患有神经根病的LDH患者的前瞻性、随机、单盲对照试验,旨在检测靶向留置导管联合“四步”推拿疗法对LDH患者的安全性和临床疗效。

方法

在基线以及治疗后的第1、3、7和28天对患者进行访视。使用背部和腿部疼痛视觉模拟量表、Oswestry功能障碍指数(ODI)以及日本矫形外科学会(JAO)的临床症状评分来衡量临床结果。

结果

该研究纳入了85名符合条件的患者。他们通过随机分组方案被分为导管组(N = 43)和无导管组(N = 42)。在测量点之间,两组在治疗后随访的第1、3和7天,视觉模拟量表(背部)存在统计学显著差异。在第1天和第3天变化具有统计学差异,与无导管组相比,导管组观察到更高的变化。两组在治疗后随访第1天的JOA和ODI评分变化存在统计学显著差异,与无导管组相比,导管组在第1天和第3天有更大变化。

局限性

样本量小,随访时间短。该研究还缺乏辅助治疗的记录,如个体患者的锻炼方案和镇痛药物治疗。

结论

与治疗前相比,两种方法在减轻疼痛强度和功能障碍方面均有效。与无导管组相比,导管组在视觉模拟量表上的下降更为显著,在短期随访的JOA和ODI评分上有更大变化。该治疗方案是安全的。

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