Moxibustion for Knee Osteoarthritis : A Protocol for a Pilot Randomized Controlled Trial

슬관절염에 대한 뜸 치료의 유효성 및 안전성 연구 : 무작위 대조 예비 임상연구 프로토콜

  • Lee, Seung-Hoon (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kim, Kun-Hyung (Dept. of acupuncture & moxibustion, Pusan National University, Korean Medicine Hospital) ;
  • Kim, Tae-Hun (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kim, Jung-Eun (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kim, Joo-Hee (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kang, Kyung-Won (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Jung, So-Young (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Kim, Ae-Ran (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Park, Hyo-Ju (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Shin, Mi-Suk (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine) ;
  • Hong, Kwon-Eui (Dept. of acupuncture & Moxibusion, College of Oriental Medicine, Dae-Jeon University) ;
  • Choi, Sun-Mi (Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine)
  • 이승훈 (한국한의학연구원 침구경락연구그룹) ;
  • 김건형 (부산대학교 한방병원 침구과) ;
  • 김태훈 (한국한의학연구원 침구경락연구그룹) ;
  • 김정은 (한국한의학연구원 침구경락연구그룹) ;
  • 김주희 (한국한의학연구원 침구경락연구그룹) ;
  • 강경원 (한국한의학연구원 침구경락연구그룹) ;
  • 정소영 (한국한의학연구원 침구경락연구그룹) ;
  • 김애란 (한국한의학연구원 침구경락연구그룹) ;
  • 박효주 (한국한의학연구원 침구경락연구그룹) ;
  • 신미숙 (한국한의학연구원 침구경락연구그룹) ;
  • 홍권의 (대전대학교 한의과대학 침구학교실) ;
  • 최선미 (한국한의학연구원 침구경락연구그룹)
  • Received : 2011.10.27
  • Accepted : 2011.12.01
  • Published : 2011.12.27

Abstract

Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

Keywords

References

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