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Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial
  1. Man-Suk Hwang1,2,
  2. Kwang-Ho Heo1,
  3. Hyun-Woo Cho2,
  4. Byung-Cheul Shin1,3,
  5. Hyeon-Yeop Lee1,2,
  6. In Heo1,2,
  7. Nam-Kwen Kim4,
  8. Byung-Kwan Choi5,
  9. Dong-Wuk Son6,
  10. Eui-Hyoung Hwang1,3
  1. 1Department of Rehabilitation Medicine of Korean Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea
  2. 2Department of Korean Medical Science, School of Korean Medicine, Pusan National University, Yangsan, South Korea
  3. 3Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea
  4. 4Department of Ophthalmology & Otolaryngology and Dermatology, School of Korean Medicine, Pusan National University, Yangsan, South Korea
  5. 5Department of Neurosurgery, Medical Research Institute, Pusan National University Hospital, Busan, South Korea
  6. 6Department of Neurosurgery, Yangsan Pusan National University Hospital, Yangsan, South Korea
  1. Correspondence to Eui-Hyoung Hwang; taichi20{at}paran.com

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250.

  • COMPLEMENTARY MEDICINE
  • NEUROSURGERY
  • PAIN MANAGEMENT
  • REHABILITATION MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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