Hwang Man-Suk, Heo Kwang-Ho, Cho Hyun-Woo, Shin Byung-Cheul, Lee Hyeon-Yeop, Heo In, Kim Nam-Kwen, Choi Byung-Kwan, Son Dong-Wuk, Hwang Eui-Hyoung
Department of Rehabilitation Medicine of Korean Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea Department of Korean Medical Science, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
Department of Rehabilitation Medicine of Korean Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea.
BMJ Open. 2015 Feb 4;5(2):e007031. doi: 10.1136/bmjopen-2014-007031.
Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described.
This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment.
Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences.
This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250.
腰椎手术后复发性或持续性下腰痛很常见，但通常控制不佳。以往关于腰椎手术后非急性疼痛的随机对照试验存在缺陷。本文描述了一项旨在治疗腰椎手术后疼痛并改善功能的随机对照试验的设计和方案。
本研究是一项试点随机、活性对照、评估者盲法试验。腰椎手术后出现复发性或持续性下腰痛（定义为视觉模拟量表值≥50 mm），伴或不伴有腿痛的患者，将被随机分配到电针加常规护理组或仅常规护理组。两组患者在从随机分组开始的4周治疗期内，每周将接受两次常规护理管理，包括物理治疗和患者教育。分配到电针加常规护理组的患者在4周治疗期内还将每周接受两次电针治疗。主要结局将由盲法评估者使用100 mm下腰痛视觉模拟量表进行测量。次要结局将使用欧洲五维健康量表和奥斯威斯利功能障碍指数进行测量。主要和次要结局将在治疗后4周和8周进行测量。
将从所有参与者处获得书面知情同意书。本研究于2013年9月获得釜山国立大学韩国医院机构审查委员会（IRB）的批准（IRB批准号2013012）。研究结果将发表在同行评审期刊上，并在国内和国际会议上展示。
本试验已在美国国立卫生研究院临床试验注册中心注册：NCT01966250。
