Department of Anesthesiology and Pain Medicine, Catholic Kwandong University, International St. Mary's Hospital, Incheon, South Korea.
Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.
Medicine (Baltimore). 2022 Mar 4;101(9):e28983. doi: 10.1097/MD.0000000000028983.
INTRODUCTION: The prevalence of lumbosacral radiculopathy is estimated to be approximately 3% to 5% in patient populations. Lumbosacral radiculopathy is largely caused by a complex interaction between biomechanical and biochemical factors. Nerve block therapy (NBT) mainly treats lumbosacral radiculopathy by improving the biochemical factors, whereas acupotomy mainly focuses on improving the biomechanical factors. Therefore, it is thought that synergistic effects may be obtained for the treatment of lumbosacral radiculopathy when both NBT and acupotomy are combined. However, no study in China and Korea, where acupotomy is majorly provided, has reported the effects of such a combination treatment. Therefore, this study aimed to evaluate the safety, effectiveness, and cost-effectiveness of the concurrent use of a deeply inserted acupotomy and NBT for the treatment of lumbosacral radiculopathy. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded, randomized controlled trial, which will include 50 patients with lumbosacral radiculopathy. After patients voluntarily agree to participate in the study, they will be screened, and will undergo necessary examinations and tests according to the protocol. Those who satisfy the selection criteria will be randomly assigned to either the NBT + acupotomy or NBT groups in a 1:1 ratio. Both groups will undergo 2 NBTs once every 2 weeks from 1 week after the screening test. The treatment group will receive additional acupotomy twice a week for 4 weeks. The primary endpoint is the Oswestry Disability Index, whereas the secondary endpoints are the Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation. The measurements will be made at 0, 2, 4, and 8 weeks. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085). We intend to submit the results of the trial to a peer-reviewed journal and/or conferences.
简介：腰骶神经根病的患病率在患者人群中估计约为 3%至 5%。腰骶神经根病主要是由生物力学和生化因素的复杂相互作用引起的。神经阻滞疗法（NBT）主要通过改善生化因素来治疗腰骶神经根病，而针刀主要侧重于改善生物力学因素。因此，当 NBT 和针刀联合使用时，治疗腰骶神经根病可能会产生协同作用。然而，在中国和韩国（针刀主要提供的地方），尚无研究报告这种联合治疗的效果。因此，本研究旨在评估深部针刀与 NBT 联合使用治疗腰骶神经根病的安全性、有效性和成本效益。
方法/设计：这是一项开放标签、平行、评估者盲法、随机对照试验，将包括 50 例腰骶神经根病患者。患者自愿同意参与研究后，将进行筛选，并根据方案进行必要的检查和测试。符合选择标准的患者将以 1:1 的比例随机分配到 NBT+针刀或 NBT 组。两组均在筛选测试后 1 周内每 2 周接受 2 次 NBT。治疗组将在 4 周内每周接受 2 次针刀治疗。主要终点是 Oswestry 残疾指数，次要终点是数字评分量表、欧洲生活质量 5 维度、麦吉尔疼痛问卷、Roland-Morris 残疾问卷、安全性评估和经济可行性评估。测量将在 0、2、4 和 8 周时进行。
伦理和传播：该试验已获得天主教关东大学国际圣玛丽医院伦理委员会的完全伦理批准（IS20OISE0085）。我们打算将试验结果提交给同行评审期刊和/或会议。
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