췌장염 환자의 복통 호전을 위한 전침 및 이침 치료 예비 임상연구 프로토콜

Abstract

Objectives : The purpose of this study is to evaluate the feasibility of further acupuncture research as an effective alternative and safe treatment for abdominal pain control in patients with pancreatitis. Methods and Results : This study is an open-label, assessment–blind, parallel designed pilot clinical trial. Thirty participants will be assigned to the acupuncture group(n=15) and usual care group(n=15). All patients will receive the conventional standard-of-care(SOC) therapy, but only the experimental group will receive acupuncture therapy six times a week, and the duration of acupuncture therapy will be held up to 12 weeks or until the pains are to be resolved. For the conventional SOC therapy, painkiller will be given. In treatment group, the subjects will receive the identical SOC therapy in combination with electroacupuncture therapy on twelve acupuncture points(LI4, PC6, SP6, GB39, ST36, ST37), and auricular acupuncture therapy on five auricular acupuncture points(Sympathetic, Shen Men, Abdomen, Pancreas gall, and Spleen). The primary outcome will be measured using the visual analogue scale(VAS), and the secondary outcome will be measured using the painkiller demand, quality of life index and severity of pancreatitis by abdominal computed tomography(CT). Assessments will be made at baseline and at week 1, 4, 8 and 12. Results of abdominal CT will be evaluated at baseline and at week 12. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for abdominal pain in patients with pancreatitis.