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http://dx.doi.org/10.14406/acu.2015.014

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  

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)
Publication Information
Korean Journal of Acupuncture / v.32, no.3, 2015 , pp. 99-107 More about this Journal
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
Geochangmanryeung-dan; acupuncture; epidural steroid injection; spinal stenosis;
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