Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Efficacy and Safety of Miniscalpel Acupuncture in Knee Degenerative Osteoarthritis Patients: A Study Protocol for a Randomized Controlled Pilot Trial

퇴행성 슬관절염 환자에 대한 도침요법의 효능 및 안전성 연구: 임상예비연구

  • Jun, Seungah (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University) ;
  • Park, Mu Seob (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University) ;
  • Oh, Se Jung (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University) ;
  • Lee, Jung Hee (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University) ;
  • Gong, Han Mi (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University) ;
  • Choi, Seong Hun (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Hwangbo, Min (Department of Oriental Ophthalmology and Otolaryngology and Dermatology, College of Korean Medicine, Daegu Haany University) ;
  • Lee, Hyun-Jong (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University) ;
  • Kim, Jae Soo (Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daegu Haany University)
  • 전승아 (대구한의대학교 한의과대학 침구의학교실) ;
  • 박무섭 (대구한의대학교 한의과대학 침구의학교실) ;
  • 오세정 (대구한의대학교 한의과대학 침구의학교실) ;
  • 이정희 (대구한의대학교 한의과대학 침구의학교실) ;
  • 공한미 (대구한의대학교 한의과대학 침구의학교실) ;
  • 최성훈 (대구한의대학교 한의과대학 해부학교실) ;
  • 황보민 (대구한의대학교 한의과대학 안이비인후피부과학교실) ;
  • 이현종 (대구한의대학교 한의과대학 침구의학교실) ;
  • 김재수 (대구한의대학교 한의과대학 침구의학교실)
  • Received : 2016.05.30
  • Accepted : 2016.06.16
  • Published : 2016.06.27
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Abstract

Objectives : The Knee degenerative osteoarthritis patients are not satisfied with the conventional therapies of KDOA, which results in the use of alternative therapies. The miniscalpel acupuncture is effective in treating chronic soft tissue, releasing contractures. However, there is little scientific evidence supporting the use of miniscalpel acupuncture in knee degenerative osteoarthritis. This study was designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis patients. Methods : We describe the protocol for a randomized controlled pilot clinical trial of 5 weeks duration. Twenty patients will be recruited and randomly allocated to two treatment groups: miniscalpel acupuncture treatment(experimental group); and acupuncture and electro-acupuncture treatment(control group). Miniscalpel acupuncture will be performed once with a 1-week interval for 3 weeks. Electro-acupuncture will be administered twice per week for a period of 3 weeks. The primary outcomes will be measured by visual analogue scale and range of motion. The secondary outcomes will be short-form McGill Pain Questionnaire and Western Ontario and McMaster Universities Osteoarthritis Index. Both primary and secondary outcomes will be measured at baseline and at 1, 2, 3 and 5 weeks(i.e. 2 weeks after treatment completion). Conclusions : This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture in knee degenerative osteoarthritis.

목적 : 본 연구는 퇴행성 슬관절염 환자들을 대상으로 도침치료가 통증을 감소시키는데 효과적이고 안전한 치료법임을 증명하기에 적합한지를 알아보기 위한 예비연구이다. 방법 : 본 연구는 5주간 진행되는 무작위배정 대조군 예비임상연구이며, 총 20명의 피험자들은 시험군(도침치료)과 대조군(침치료＋전침치료)으로 무작위 배정된다. 시험군의 경우에는 주 1회, 3주간 총 3회의 도침치료를 실시하고 대조군의 경우에 주 2회, 3주간 총 6회의 침치료와 전침치료를 받게된다. 1차 유효성 평가변수는 통증에 대한 Visual analogue system와 관절가동범위를, 2차 유효성 평가변수는 Short form McGill pain questionnaire와 Western Ontario and McMaster Universities Osteoarthritis Index로 측정한다. 평가는 시험시작 전, 시험 1주, 2주, 3주 및 5주후에 이루어지게 된다. 결론 : 본 연구는 추후 본격적인 무작위배정 대조군 임상시험을 위한 예비연구로서, 본 연구를 통해 퇴행성 슬관절염에 있어서 도침치료가 임상적으로 유효함을 증명할 수 있는 근거를 마련해 줄 것이라 사료된다.

Keywords

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