RecruitingNot ApplicableNCT07493902

Acupuncture for Post-Stroke Dysphagia: A Clinical Study

Acupuncture Treatment for Post-Stroke Dysphagia: A Prospective, Multicenter Clinical Study of a Cohort-Based Embedded Partially Randomized Preference Trial

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Enrollment

3,232 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acupuncture Post-stroke Dysphagia

Summary

Employing a nested design, a partially randomized preference study (Study II) is embedded within a prospective, multicenter cohort study (Study I). The cohort study, with acupuncture as the exposure factor, explores the clinical efficacy and health economic value of different integrated Chinese and Western medicine treatment protocols. The nested partially randomized preference study of different acupuncture protocols generates high-level evidence through randomized cohorts while supplementing real-world decision-making with preference cohort data.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Age between 18 and 80 years old, no gender restrictions;
Meets diagnostic criteria for ischemic or hemorrhagic stroke, confirmed by CT or MRI, with disease duration within one year;
Meets diagnostic criteria for dysphagia, with FOIS grade 2-4;
Vital signs stable, able to understand and cooperate with study procedures; ⑤ Patient or legal representative agrees to sign informed consent.

Exclusion Criteria4

Dysphagia not caused by stroke, but resulting from other neurological disorders (e.g., motor neuron disease, myasthenia gravis) or organic lesions (e.g., tumors);
Patients with psychiatric disorders or severe cognitive impairment who cannot cooperate with treatment;
Patients with an expected survival time of less than 3 months; ④ Individuals with contrast medium allergy;
Patients with severe needle phobia who cannot tolerate the procedure; ⑥ Pregnant women, those planning pregnancy, or lactating women; ⑦ Individuals who have participated in other clinical trials or received acupuncture within the past week.

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Interventions

PROCEDUREacupuncture

Tongguan Liqiao Acupuncture Group： ①Acupoint Selection The treatment is phased, combining main and adjunct points. Main points: Neiguan (PC6), Shuigou (GV26), Sanyinjiao (SP6). Adjunct points: Fengchi (GB20), Wangu (GB12), Yifeng (TE17). Treatment is phased, combining primary and auxiliary points. ② Location and Operation Point locations follow the 2006 National Standard of the People's Republic of China (GB/T12346-2006) "Acupoint Names and Locations." Manipulation follows the SCM 88-2025 International Standard for Traditional Chinese Medicine Techniques: Acupuncture Method for Tongguan Liqiao to Treat Post-Stroke Dysphagia. Conventional Acupuncture Group： The "protocol scheme" habitually applied by each research unit (sub-center). Once designated, the protocol scheme shall not be altered and must be strictly adhered to.