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

이현종; 이초인; 이사람; 곽민아; 곽상규; 노운석; 정진용

doi:10.14406/acu.2015.014

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

Korean journal of acupuncture, v.32 no.3, 2015년, pp.99 - 107

이현종 (대구한의대학교 한의과대학 침구의학교실) , 이초인 (대구한의대학교 한의과대학 침구의학교실) , 이사람 (대구가톨릭의과대학교병원 마취통증의학과) , 곽민아 (대구한의대학교 한의과대학 내과학교실) , 곽상규 (대구가톨릭대학교 통계학교실) , 노운석 (대구가톨릭의과대학교병원 마취통증의학과) , 정진용 (대구가톨릭의과대학교병원 마취통증의학과)

Abstract ▼ AI-Helper

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.

주제어

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문제 정의

Therefore, we aim to evaluate the efficacy and safety of Geochang-manryeung-dan(GMD) and acupuncture, which have been frequently used in clinical practice. In this manuscript, we describe a protocol for a randomized, controlled, pilot clinical trial of GMD and acupuncture in SS patients.
The study is a randomized controlled pilot clinical trial. It is designed to obtain basic data for a further large-scale trial on the efficacy and safety of GMD and acupuncture on patient with SS treated by epidural steroid injection.

가설 설정

We hypothesize that GMD and acupuncture treatment in combination with epidural steroid injection will reduce the severity of SS, measured by visual analogue scale(VAS) and self-rated walking distance, significantly more than epidural steroid injection alone.

제안 방법

The control group will only receive epidural steroid injection 3 times(once per 2 weeks), and the experimental group will receive herbal medications (GMD) and acupuncture(2 times per week, total 12 times) for 6 weeks in addition to epidural steroid injection. Assessments will be performed at baseline and again at 2, 4, 6, and 8 weeks. The last assessment(at 8 weeks) will be performed 2 weeks after treatment cessation.
In this study, the primary outcome will be measured by VAS and self-rated walking distance. The secondary outcome will be measured by PainVision, the short-form McGill Pain Questionnaire(SF-MPQ), and Oswestry Disability Index(ODI).
. The ODI consists of 10 items about daily activities, including inventories of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling. Each item is measured on a scale of 0∼5 points.
Any reported events will be recorded throughout the study and vital signs will be monitored at each visit. The participants will be requested to voluntarily report information about adverse events, and the researcher will confirm the occurrence of adverse events through methods, such as a medical interview. The date of occurrence, degree of adverse events, causal relationship with the treatment, other treatments or medications that are suspected to cause the adverse event, and treatment for the adverse event will be recorded in detail.

대상 데이터

As a pilot study, we plan to recruit 20 participants with SS. Each group will include 10 participants with drop rate as 20%.

데이터처리

Comparison of characteristics between experimental and control groups will be analysed using two-sample t-test or Mann-Whitney U-test according to data normality for quantitative variables, and chi-square test for qualitative variables. Analysis of effects for the primary outcome measurements(VAS and self-rated walking distance) and secondary outcome measurements(PainVision, SF-MPQ, and ODI) by time(baseline, 2, 4, 6, and 8 week), group, and interaction(time difference by group) will be performed using repeated measure two-factor analysis. Multiple comparisons will also be performed.

이론/모형

In this study, the primary outcome will be measured by VAS and self-rated walking distance. The secondary outcome will be measured by PainVision, the short-form McGill Pain Questionnaire(SF-MPQ), and Oswestry Disability Index(ODI). Both primary and secondary outcomes will be measured at baseline, 2, 4, 6, and 8 weeks.

성능/효과

2) GMD: GMD is adjusting prescription from Boanmanryeong-dan recorded in Bang Yak Hap Pyun. Though there is no previous study about GMD, it has been used generally in the treatment of neuralgia.

후속연구

The study is a randomized controlled pilot clinical trial. It is designed to obtain basic data for a further large-scale trial on the efficacy and safety of GMD and acupuncture on patient with SS treated by epidural steroid injection. This study protocol follows the tenets of the Declaration of Helsinki and Korean Good Clinical Practice, and has been approved by the Institutional Review Board of Daegu Catholic University Hospital(MDCR-14-004).
Therefore, we have designed this pilot study to guide a large-scale trial for evaluating the efficacy and safety of herbal medicine and acupuncture in patients with SS. We expect this pilot study can be used to provide clinical information and basic data for a future large-scale trial.

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