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KMID : 1129720150320030099
Korean Journal of Acupuncture
2015 Volume.32 No. 3 p.99 ~ p.107
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
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
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.
KEYWORD
Geochangmanryeung-dan, acupuncture, epidural steroid injection, spinal stenosis
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