脳卒中後の手の機能障害に対する電鍼治療パラメータの最適化：直交設計を用いた多腕無作為化比較試験プロトコル

Hand dysfunction following stroke, especially during the flaccid paralysis phase, significantly impairs patients' motor abilities and daily functioning. Electroacupuncture (EA) is widely used in post-stroke rehabilitation; however, inconsistent clinical outcomes and lack of standardised treatment parameters have limited its broader adoption.This protocol describes a randomised controlled trial designed to determine optimal EA parameters for post-stroke hand dysfunction using an orthogonal experimental design.

This protocol presents a single-centre, randomised controlled trial design with 10 arms. A total of 110 patients with post-stroke hand dysfunction will be randomly assigned to nine electroacupuncture groups or one sham acupuncture group in equal proportions. Participants will receive 12 treatment sessions over 2 weeks. The EA groups are designed based on a four-factor, three-level orthogonal design to systematically evaluate the main effects of acupoint selection, stimulation frequency, needle thickness and treatment duration. The primary outcome is the effective response rate, defined as reduction in the Chinese Stroke Scale (CSS) score at 2 weeks. Secondary outcomes include assessments with the Modified Lindmark Rating Scale, range of motion measures, Modified Barthel Index and hand motor subscores of the CSS. As this is a trial protocol, results are not yet available. Statistical analyses will be conducted after completion of recruitment and follow-up according to the prespecified analysis plan. Safety and adverse events will be monitored throughout the study.

This trial is designed to address the current lack of evidence-based standardisation of EA parameters for post-stroke hand dysfunction. By systematically evaluating key treatment components using an orthogonal experimental design, the study aims to identify optimal EA strategies and provide a methodological framework to improve consistency, reproducibility and clinical effectiveness in post-stroke hand rehabilitation.

This manuscript describes a study protocol and does not report any data from participants at this stage. Ethical approval for the planned trial was obtained from the Medical Ethics Committee of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Approval No. TYLL2024(K)072). Written informed consent will be obtained from all participants prior to enrolment. The results of the study will be disseminated through peer-reviewed journals and academic conferences.

ITMCTR2024000819.