Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Efficacy of Acupuncture in Treating Upper Abdominal Pain in Cancer Patients: Study Protocol for A Randomized Controlled Pilot Clinical Trial

암환자의 상복부 통증 치료에 대한 침의 효과: 무작위배정 대조군 연구 예비임상시험 프로토콜

  • Jung, Jin-Yong (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University of Daegu) ;
  • Lee, Hyun-Jong (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daegu Haany University) ;
  • Seo, Jung-Chul (Comprehensive and Integrative Medicine Institute, School of Medicine, Catholic University of Daegu) ;
  • Min, Bo-Mi (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University of Daegu) ;
  • Cho, Min-Su (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University of Daegu) ;
  • Shin, Im-Hee (Department of Medical Statistics, School of Medicine, Catholic University of Daegu) ;
  • Roh, Woon-Seok (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University of Daegu) ;
  • Kwak, Min-Ah (Department of Internal Medicine, College of Oriental Medicine, Daegu Haany University)
  • 정진용 (대구가톨릭대학교병원 마취통증의학과) ;
  • 이현종 (대구한의대학교 한의과대학 침구의학과교실) ;
  • 서정철 (통합의료진흥원) ;
  • 민보미 (대구가톨릭대학교병원 마취통증의학과) ;
  • 조민수 (대구가톨릭대학교병원 마취통증의학과) ;
  • 신임희 (대구가톨릭대학교 통계학교실) ;
  • 노운석 (대구가톨릭대학교병원 마취통증의학과) ;
  • 곽민아 (대구한의대학교 한의과대학 내과학교실)
  • Received : 2014.03.17
  • Accepted : 2014.03.21
  • Published : 2014.03.27
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Abstract

Objectives : This study was designed to evaluate the feasibility of further acupuncture research as an effective and safe treatment for reducing cancer-related upper abdominal pain in patients treated with Neurolytic celiac plexus block(NCPB). Methods : This study is a randomized controlled pilot clinical trial of 3-week duration. Fourteen patients will be recruited and randomly allocated to 2 groups: an acupuncture plus NCPB group(experimental group) and a NCPB group(control group). All patients will undergo one session of NCPB, but only the experimental group will receive three acupuncture sessions a week for 2 weeks(6 in total). The primary outcome will be measured using the visual analogue scale, and the secondary outcome will be measured using the Painvision system and the consumption of additional analgesics. Assessments will be made at baseline and at 1, 2, and 3 weeks thereafter(that is, the 3-week assessment will be made 1 week after treatment cessation). Conclusions : This clinical trial will inform the design of a full-scale trial. The outcomes will provide information to facilitate the incorporation of acupuncture into existing pain management methods such as NCPB in the treatment of cancer-related upper abdominal pain patients.

목적 : 본 연구는 복강신경총 차단술을 시행한 상복부 암성통증 환자들을 대상으로 침치료가 암관련 통증을 감소시키는 효과적이고 안전한 치료법임을 증명하기에 적합한지를 알아보기 위한 예비연구이다. 방법 : 본 연구는 3주간 진행되는 무작위배정 대조군 예비임상연구이며, 총14명의 피험자들은 시험군 (복강신경총차단술+침치료)과 대조군 (복강신경총차단술)으로 무작위배정된다. 모든 피험자들은 복강신경총 차단술을 1회 시술 받으며, 오직 시험군의 경우에만 주 3회, 2주간 총 6회의 추가적인 침치료를 시술받을 예정이다. 1차 유효성 평가변수는 통증에 대한 VAS를, 2차 유효성 평가변수는 Painvison과 추가 진통제 소비량을 측정한다. 평가는 시험시작 전, 시험 1주, 2주 및 3주후에 이루어지게 된다. 결론 : 본 연구는 추후 본격적인 무작위배정 대조군 임상시험을 위한 예비연구로서, 본 연구를 통해 상복부 암성 통증치료에 있어서 침치료가 복강신경총차단술과 같이 병행치료 했을 때 임상적으로 유효함을 증명할 수 있는 근거를 마련해 줄 것이라 사료된다.

Keywords

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