JMIR Publications

ABSTRACT

Background:

Post-stroke dysphagia is a common and serious complication of stroke and is associated with malnutrition, aspiration pneumonia, reduced quality of life, and increased mortality. Although multidisciplinary rehabilitation can improve swallowing function, its clinical application may be limited by equipment dependence, limited accessibility in primary care settings, and insufficient efficacy in patients with severe or chronic dysphagia. Acupuncture may improve swallowing function by modulating swallowing-related neural excitability and enhancing local blood flow. Interactive acupuncture, which combines acupuncture stimulation with active swallowing-related patient participation, may offer a practical and patient-centered treatment approach for post-stroke dysphagia.

Objective:

This study aims to evaluate the clinical efficacy and safety of interactive acupuncture for patients with post-stroke dysphagia.

Methods:

This is a prospective, multicenter, randomized, parallel-group controlled clinical trial protocol. A total of 100 participants with post-stroke dysphagia will be recruited and randomly assigned to either an interactive acupuncture group or a control group. Participants in the control group will receive conventional acupuncture with needle retention at the same acupoints. Both groups will receive foundational treatment, including basic Western medical therapy and standard stroke acupuncture. The intervention will include 14 treatment sessions administered 6 times per week, followed by a 1-month follow-up. Outcomes will be assessed at baseline, during treatment after sessions 3 and 7, after completion of treatment at session 14, and at the 1-month follow-up. Efficacy outcomes will include swallowing function scale scores, the incidence of penetration or aspiration, surface electromyography findings, videofluoroscopic swallowing study results, quality of life, and psychological assessments. Safety outcomes will be recorded throughout the trial.

Results:

The trial was registered with the International Traditional Medicine Clinical Trial Registry. Participant recruitment is planned from January 1, 2026, to June 1, 2027. After completion, this trial will determine whether interactive acupuncture provides greater improvement in swallowing function than conventional acupuncture with needle retention and will evaluate objective swallowing-related measures, patient-reported outcomes, and intervention safety.

Conclusions:

This randomized controlled trial will assess the clinical efficacy and safety of interactive acupuncture for post-stroke dysphagia. The findings are expected to provide evidence for a standardized, practical, and patient-compliant acupuncture protocol that may be suitable for broader clinical application. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2025002622; https://itmctr.ccebtcm.org.cn/. Protocol version: 2025-KY-17; version date: June 19, 2025.