Response to Korean medicine with acupotomy in patients with cognitive impairment in primary care: A multicenter registry protocol.

Abstract

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.