Goo Bonhyuk, Ryoo Dek-Woo, Kim Eun-Jung, Nam Dongwoo, Lee Hyun-Jong, Kim Jae-Soo, Park Yeon-Cheol, Baek Yong-Hyeon, Seo Byung-Kwan
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Department of Acupuncture & Moxibustion Medicine, College of Oriental Medicine, Dongguk University, 123, Dongdae-ro, Gyeongju-si, Gyeongsangbuk-do, 38066, Republic of Korea.
Trials. 2018 Sep 10;19(1):484. doi: 10.1186/s13063-018-2864-4.
A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol.
METHOD/DESIGN: This is a multicenter, randomized, patient-assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19-70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland-Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening.
The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD.
ClinicalTrials.gov, NCT03236753 . Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea, KCT0002439 . Registered on August 1, 2017.
腰椎间盘突出症（LHIVD）是一个常见问题，通常会导致下背部疼痛和表现为放射性疼痛的神经症状。多项研究报告称，埋线针灸（TEA）对LHIVD的治疗有效。然而，这些研究质量较低，因此在这方面几乎没有TEA有效性的临床证据。本研究的目的是确立TEA治疗LHIVD患者疼痛、功能及生活质量方面疗效和安全性的临床证据。该研究采用严格设计的全面随机临床试验（RCT）方案。
方法/设计：这是一项多中心、随机、患者与评估者双盲、假手术对照试验，有两个平行组。将招募70例19至70岁、100毫米视觉模拟量表（VAS）下背部疼痛超过40毫米的LHIVD患者，并随机分配到TEA组和假埋线针灸（STEA）组。两组均将在23个预先确定的穴位上每周治疗一次，共八周；STEA组将使用去掉线的针，而TEA组将采用常规埋线针灸。八周后下背部疼痛100毫米VAS的变化将作为主要结局进行评估。此外，放射性疼痛100毫米VAS、Oswestry功能障碍指数、Roland-Morris功能障碍问卷、欧洲五维健康量表5级以及整体疗效感受将作为次要结局进行测量和分析。所有结局将在基线时以及筛查后的第4、8、12和16周进行评估。
本试验结果将有助于确立TEA治疗LHIVD患者的临床证据。
ClinicalTrials.gov，NCT03236753。于2017年8月2日注册。大韩民国临床研究信息服务中心，KCT0002439。于2017年8月1日注册。
