Copyright
©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
Response to Korean medicine with acupotomy in patients with cognitive impairment in primary care: A multicenter registry protocol
Hyungsun Jun, Myungseok Ryu, Hyocheong Chae, Hongmin Chu, Kwangho Kim, Do-Eun Lee, Hanbit Jin, Sungjun Joo, Dasol Park, Jungtae Leem, Hyung Won Kang
Hyungsun Jun, Sungjun Joo, Dasol Park, Jungtae Leem, Department of Diagnostics, Wonkwang University, Iksan 54538, South Korea
Myungseok Ryu, Hyocheong Chae, Hongmin Chu, Kwangho Kim, Korean Medical Society of Acupotomology, Seoul 07208, South Korea
Kwangho Kim, Haseo Public Health Subcenter, Buan Public Health Center, Buan 56333, South Korea
Do-Eun Lee, Hyung Won Kang, Department of Korean Neuropsychiatry Medicine, Wonkwang University, Iksan, Jeollabuk-do 54538, South Korea
Hanbit Jin, Department of Preventive Medicine, Dongshin University, Naju 58245, South Korea
Sungjun Joo, Department of Korean Rehabilitation Medicine, Dongshin Korean Medicine Hospital, Seoul 07999, South Korea
Jungtae Leem, Research Center of Traditional Korean Medicine, Wonkwang University, Iksan 54538, South Korea
Jungtae Leem, Department of Il-won Integrated Medicine, Wonkwang University Korean Medicine Hospital, Iksan 54538, South Korea
Hyung Won Kang, Korean Medicine Cognitive Disorder Research Center, Wonkwang University, Iksan 54538, South Korea
Hyung Won Kang, Department of Digital Healthcare, Graduate school of JABA, Wonkwang University, Iksan 54538, South Korea
Co-first authors: Hyungsun Jun and Myungseok Ryu.
Co-corresponding authors: Jungtae Leem and Hyung Won Kang.
Author contributions: Jun H, Ryu M, Leem J, Kang HW designed the research study. Jun H, Chae H, Chu H, Kim K performed the research; Jun H, Jin H, Joo S wrote the draft of the manuscript. Ryu MS, Chae H, Chu H, Kim K, Lee D, Park D, Leem J, Kang HW critically reviewed and edited the manuscript; Ryu M, Leem J, Kang HW supervised the study. All authors have read and approved the final manuscript.
Supported by The Korea Health Technology Project through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, Republic of Korea, No. RS-2023-KH138802.
Institutional review board statement: The study was reviewed and approved by the Public Institutional Review Board designated by Ministry of Health and Welfare (Approval No. P01-202410-01-022).
Informed consent statement: All study participants, or their legal guardians, will provide informed written consent prior to study enrollment.
Conflict-of-interest statement: Hyung Won Kang received research funding from the Korea Health Technology Project through the Korea Health Industry Development Institute, which is funded by the Ministry of Health and Welfare, Republic of Korea. However, the funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
STROBE statement: The authors have read the STROBE Statement–checklist of items, and the manuscript was prepared and revised according to the STROBE Statement–checklist of items.
Data sharing statement: sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Jungtae Leem, MD, PhD, Department of Diagnostics, Wonkwang University, Iksan-daero, 460, Iksan 54538, Jeollabuk-do, South Korea.
julcho@naver.com
Received: March 25, 2025
Revised: April 14, 2025
Accepted: May 21, 2025
Published online: September 6, 2025
Processing time: 104 Days and 18.1 Hours
BACKGROUND
Mild cognitive impairment (MCI) and subjective cognitive decline (SCD) are risk indicators for dementia and require ongoing management. Traditional Korean medicine (TKM) commonly employs acupuncture and herbal medicine for cognitive impairment; yet, clinical research on acupotomy is lacking. Although most TKM treatments occur in primary care, the research is largely hospital-based. This registry was established to systematically collect real-world data on the clinical progress, efficacy, and safety of TKM with acupotomy for patients with MCI or SCD in primary care. It is hypothesized that TKM with acupotomy improves cognitive function and is safe for these patients.
AIM
To establish an MCI or SCD registry of patients receiving TKM, including acupotomy, to analyze its clinical efficacy and safety.
METHODS
This observational registry study will be conducted across 22 medical institutions; approximately 500 participants will be recruited. Data—sociodemographic information, medication history, height, weight, vital signs, and assessment questionnaires (Montreal Cognitive Assessment-Korean, short form of Korean-Everyday Cognition, Numeric Rating Scale, Korean version of the Insomnia Severity Index)—will be collected at 3-month intervals over a year. This study will also document the TKM treatment administered and any adverse events. Routine TKM procedures will be followed, with acupuncture and acupotomy administered as per protocol; treatments including herbal medicine, Chuna therapy, and moxibustion may be administered at the practitioner’s discretion.
RESULTS
The registry will capture a wide range of real-world clinical data regarding demographic profiles, treatment processes, and adverse events. This detailed documentation is expected to clarify patient characteristics, evaluate the clinical course, and identify factors that may affect cognitive improvement in patients with MCI and SCD.
CONCLUSION
This research may provide evidence supporting acupotomy for cognitive impairment in primary care by confirming its efficacy and safety, providing preliminary evidence for TKM-based interventions aimed at improving cognitive function.
Core Tip: This multicenter registry study will investigate real-world clinical data from patients with mild cognitive impairment and subjective cognitive decline treated with traditional Korean medicine (TKM), including acupotomy. It is the first registry-based study to focus on this population in primary care. By collecting information on demographics, cognitive function, treatment procedures, and adverse events, this study aims to examine the safety and effectiveness of comprehensive TKM treatment, including acupotomy. Findings from this registry are expected to serve as a foundation for planning and conducting future clinical studies.
