Xia Jing-Chun, Huang Yu-Cheng, Wu Ke, Pang Jian, Shi Ying
Shi's Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Institute of Traumatology & Orthopedics, Shanghai Academy of Traditional Chinese Medicine, Shanghai, People's Republic of China.
J Pain Res. 2024 Apr 8;17:1381-1391. doi: 10.2147/JPR.S448631. eCollection 2024.
Chinese herbal medicine and electroacupuncture (EA) have been used to control pain for many decades in China. We aim to explore the efficacy of intervening patients whose discogenic sciatica symptoms lasting longer than 3 months with these conservative treatments.
This is a single-center, parallel-group, patient-unblinded Randomized Controlled Trial (RCT) with blinded outcome assessment and statistician. One hundred and twenty-four patients will be assigned randomly into 2 groups including conservative treatment group (Shenxie Zhitong capsule combined with EA treatment) and Nonsteroidal Anti-inflammatory Drugs (Nonsteroidal Anti-inflammatory Drugs, NSAIDs) control group (Celecoxib) in a 1:1 ratio. The trial involves a 4-week treatment along with follow-up for 6 months. The primary outcome is the leg pain intensity measured by the visual analogue scale (VAS) at 6 months after randomization. Secondary outcomes include leg pain intensity at other time points, back pain intensity, leg pain and back pain frequency, functional status, quality of life, return to work status and satisfaction of patients. Adverse events will also be recorded.
Through this study, we want to observe the efficacy of electroacupuncture combined with Chinese herbal medicine on pain intensity for chronic sciatica secondary to Lumbar Disc Herniation. If the final results are favorable, it is expected to be a safe, economical, and effective treatment for patients. The study design has the following limitations: the setup of control group was less than perfect; patients and doctors could not be blinded in this trial; we skipped the feasibility study. We have tried our best to minimize adverse impacts.
ChiCTR2300070884 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 25th April 2023).
在中国，中药和电针（EA）已用于控制疼痛数十年。我们旨在探讨用这些保守疗法干预椎间盘源性坐骨神经痛症状持续超过3个月的患者的疗效。
这是一项单中心、平行组、患者非盲的随机对照试验（RCT），采用盲法结局评估和统计学家。124名患者将按1:1的比例随机分为两组，包括保守治疗组（神蝎止痛胶囊联合电针治疗）和非甾体抗炎药（NSAIDs）对照组（塞来昔布）。该试验包括为期4周的治疗以及6个月的随访。主要结局是随机分组后6个月时用视觉模拟量表（VAS）测量的腿痛强度。次要结局包括其他时间点的腿痛强度、背痛强度、腿痛和背痛频率、功能状态、生活质量、重返工作状态以及患者满意度。不良事件也将被记录。
通过本研究，我们想观察电针联合中药对腰椎间盘突出继发慢性坐骨神经痛疼痛强度的疗效。如果最终结果良好，预计对患者来说是一种安全、经济且有效的治疗方法。研究设计有以下局限性：对照组设置不够完善；本试验中患者和医生无法设盲；我们跳过了可行性研究。我们已尽力将不利影响降至最低。
ChiCTR2300070884（中国临床试验注册中心，http://www.chictr.org.cn，于2023年4月25日注册）。
