• Medicine · Dec 2021

    Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized, controlled, pilot clinical trial: A study protocol.

    • Ji Hoon Han, Hyun-Jong Lee, Sang Ha Woo, Yu-Kyeong Park, Ga-Young Choi, Eun Sil Heo, Jae Soo Kim, Jung Hee Lee, Chung A Park, Woo Dong Lee, Chang Sop Yang, Ae-Ran Kim, and Chang-Hyun Han.
    • Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.
    • Medicine (Baltimore). 2021 Dec 23; 100 (51): e28175e28175.

    IntroductionLumbar spinal stenosis (LSS) is a pathological condition that causes a variety of neurological symptoms due to narrowing of the anatomical structures; usually, conservative treatment is recommended, rather than surgical treatment. Acupotomy combines conventional acupuncture with small scalpels; the procedure can be considered minimally invasive, and has recently received considerable attention in clinical practice. Still, there is a lack of data and randomized controlled trials regarding acupotomy related to LSS. Additional studies are necessary, considering the low methodological quality and small size of the study.Methods And AnalysisThis is a pragmatic, pilot, randomized controlled trial. The trial comprises 8 weeks of treatment, with 16 visits and a 4-week follow-up period. Forty participants diagnosed with LSS will be randomly assigned to either the experimental or control groups; both groups will receive acupuncture and interferential current therapy twice a week for 8 weeks, while the experimental group will receive an additional acupotomy intervention once a week for 8 weeks. The primary outcome will be assessed using the visual analog scale; the secondary outcome will be measured by self-rated walking distance, Oswestry Disability Index, and short-form McGill Pain Questionnaire. Measurements will be obtained prior to the start of the clinical trial, 4 weeks after the interventional procedure, 8 weeks after the procedure, and 4 weeks after the end of the interventional procedure. Blood tests and adverse reactions will be performed to ensure safety of the treatments.ConclusionWe expect that this study will provide basic data for future large-scale acupotomy studies regarding LSS.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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