新八罗药针疗法对腰椎间盘突出症所致坐骨神经痛患者的疗效：一项随机对照试验的研究方案

Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial.

作者信息

Lee Jinho, Shin Joon-Shik, Lee Yoon Jae, Kim Me-Riong, Ahn Yong-Jun, Park Ki Byung, Kropf Michael A, Shin Byung-Cheul, Lee Myeong Soo, Ha In-Hyuk

机构信息

Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea.

Spine Center, Cedars-Sinai Medical Center, 444 S. San Vicente Blvd, Suites 800/901, Los Angeles, CA, USA.

出版信息

Trials. 2015 Oct 12;16:455. doi: 10.1186/s13063-015-0993-6.

DOI:10.1186/s13063-015-0993-6

PMID:26459006

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4603920/

Abstract

BACKGROUND

Lumbar disc herniation is a major cause of sciatica and low back pain and imposes a heavy burden on both individual and society. While use of pharmacopuncture, a combined form of acupuncture and herbal medicine, for lumbar disc herniation is widespread in Korea and China, there is a paucity of research.

METHODS/DESIGN: This study is the protocol for a three-armed, randomized, patient, physician, and assessor-blinded controlled pilot study. Sixty patients with severe non-acute sciatic pain diagnosed with lumbar disc herniation (NRS ≥ 5, onset between 4 weeks and 6 months) will be recruited and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture with acupuncture), acupuncture, and usual care groups, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2-3 times/day and physical therapy 2 sessions/week over 4 weeks (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group during acupuncture needle retention. The second physician will administer acupuncture and pharmacopuncture in a similar manner in terms of advice and manual stimulation to maintain patient-blinding, treat the patient out of view of the initial physician, remove the additional acupuncture needle immediately, and cover the area with adhesive bandage to maintain physician-blinding. The primary endpoint will be at 5 weeks post-randomization, and the primary outcome will be Visual Analog Scale (VAS) of sciatic pain. Secondary outcomes will be VAS of low back pain, Numeric Rating Scale (NRS) of low back pain and sciatic pain, ODI, SF-36, EQ-5D, and PGIC. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.

DISCUSSION

This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation with usual care of conventional medicine and that of Korean medicine (acupuncture), monitor its safety, and serve as basis for a large-scale, multicenter trial.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02384928 , registered 27 February 2015.

摘要

背景

腰椎间盘突出症是坐骨神经痛和腰痛的主要原因，给个人和社会都带来了沉重负担。虽然针药结合（针灸与草药的联合形式）治疗腰椎间盘突出症在韩国和中国广泛应用，但相关研究较少。

方法/设计：本研究是一项三臂、随机、患者、医生和评估者双盲的对照试验方案。将招募60例被诊断为腰椎间盘突出症且伴有严重非急性坐骨神经痛（数字疼痛评分量表[NRS]≥5，发病时间在4周和6个月之间）的患者，并将其随机分为3组，每组20人，分别接受新宝针药结合疗法（针药结合）、针灸和常规护理。两个针灸组将每周接受2次单独针灸或针药结合治疗，共4周（总计8次），常规护理组将在4周内（总计8次）每天接受2 - 3次常规药物治疗，并每周接受2次物理治疗。最初的针灸医生将在两个针灸组的5个穴位（足少阳胆经30穴、足太阳膀胱经40穴、足太阳膀胱经25穴、足太阳膀胱经23穴、足少阳胆经34穴）进行针灸，并标记一个额外穴位。第二位针灸医生将在针药结合组的标记穴位进行针药结合治疗，在针灸组的针灸留针期间进行针灸。第二位医生将在建议和手法刺激方面以类似方式进行针灸和针药结合治疗，以保持患者双盲，在最初医生看不到的情况下治疗患者，立即取出额外的针灸针，并用绷带覆盖该区域以保持医生双盲。主要终点将在随机分组后5周时进行评估，主要结局指标将是坐骨神经痛的视觉模拟量表（VAS）。次要结局指标将包括腰痛的VAS、腰痛和坐骨神经痛的数字评分量表（NRS）、腰椎间盘突出症功能障碍指数（ODI）、健康调查简表（SF - 36）、欧洲五维健康量表（EQ - 5D）和患者整体印象变化量表（PGIC）。治疗后评估将在随机分组后的5、7、9和12周进行。