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Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized,controlled, pilot clinical trial: A study protocol
Authors: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  Chang-Hyun Han
Abstract:Introduction:Lumbar 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 analysis:This 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.Conclusion:We expect that this study will provide basic data for future large-scale acupotomy studies regarding LSS.
Keywords:acupotomy   lumbar spinal stenosis   pilot   pragmatic   randomized controlled trial
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