KMID : 1129720150320030099
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Korean Journal of Acupuncture 2015 Volume.32 No. 3 p.99 ~ p.107
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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
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ÀÌÇöÁ¾:Lee Hyun-Jong
ÀÌÃÊÀÎ:Lee Cho-In/ÀÌ»ç¶÷:Lee Sa-ram/°û¹Î¾Æ:Kwak Min-A/°û»ó±Ô:Kwak Sang-Gyu/³ë¿î¼®:Rho Woon-Seok/Á¤Áø¿ë:Jung Jin-Yong
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Abstract
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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.
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KEYWORD
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Geochangmanryeung-dan, acupuncture, epidural steroid injection, spinal stenosis
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