Korean Journal of Acupuncture

Society for Meridian and Acupoint (경락경혈학회)
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Efficacy and Safety of Geochangmanryeung-dan and Acupuncture on Patient with Spinal Stenosis Treated by Epidural Steroid Injection: a Study Protocol for a Randomized Controlled Pilot Trial

경막외신경차단술로 치료 중인 척추관 협착증 환자에서 거창만령단과 침의 효능 및 안전성 연구(예비임상연구)

  • Lee, Hyun-jong (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daegu Haany University) ;
  • Lee, Cho In (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daegu Haany University) ;
  • Lee, Saram (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) ;
  • Kwak, Sang Gyu (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) ;
  • Jung, Jin-yong (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University of Daegu)
  • 이현종 (대구한의대학교 한의과대학 침구의학교실) ;
  • 이초인 (대구한의대학교 한의과대학 침구의학교실) ;
  • 이사람 (대구가톨릭의과대학교병원 마취통증의학과) ;
  • 곽민아 (대구한의대학교 한의과대학 내과학교실) ;
  • 곽상규 (대구가톨릭대학교 통계학교실) ;
  • 노운석 (대구가톨릭의과대학교병원 마취통증의학과) ;
  • 정진용 (대구가톨릭의과대학교병원 마취통증의학과)
  • Received : 2015.08.04
  • Accepted : 2015.09.06
  • Published : 2015.09.27
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Abstract

Objectives : This study was designed to obtain basic data for a further large-scale trial as evaluating the efficacy and safety of Geochangmanryeung-dan(GMD) and acupuncture on patient with spinal stenosis treated by epidural steroid injection. Methods: The study is a randomized controlled pilot clinical trial, conducted over 8 weeks. Twenty participants will be recruited and randomly allocated to 2 groups: an experimental(GMD and acupuncture with epidural steroid injection) group and a control(only epidural steroid injection) group. The epidural steroid injection will be administered once per 2 weeks for 6 weeks(3 times in total). GMD will be administered as a dose of 5 pills, 3 times per day, for 6 weeks. Acupuncture will be performed 2 times per week for 6 weeks(12 times in total). The primary outcome will be measured by visual analogue scale and self-rated walking distance. The secondary outcome will be measured by PainVision, short-form McGill Pain Questionnaire, and Oswestry Disability Index. Both primary and secondary outcomes will be measured at baseline, 2, 4, 6, and 8 weeks. The last assessment(at 8 weeks) will be performed 2 weeks after treatment cessation. Conclusions : This clinical trial, as the pilot study for a future large-scale trial, will provide clinical information for evaluating the efficacy and safety of GMD and acupuncture treatment in combination with epidural steroid injection for the treatment of spinal stenosis.

Keywords

References

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