Overview
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.
Description
A nested design was employed, incorporating a partially randomized preference study (Study 2) within a prospective, multicenter cohort study (Study 1).
Study 1 (Main Cohort): A prospective, multicenter cohort study will enroll patients with post-stroke dysphagia meeting inclusion and exclusion criteria who present at the research center between January 2026 and December 2027. Acupuncture will serve as the exposure factor, naturally forming two cohorts. Primary efficacy outcomes will assess clinical efficacy of acupuncture interventions for PSD, clarify therapeutic advantages of precision acupuncture protocols, explore treatment benefits across PSD subgroups, and evaluate the efficacy and health economic value of diversified integrated Chinese-Western medical approaches to inform guideline updates with evidence-based data.
Study 2 (Embedded Study): Employing a prospective, multicenter, partially randomized preference study, we enrolled patients with post-stroke dysphagia meeting inclusion/exclusion criteria who visited the research center between January 2026 and December 2027. Acupuncture intervention grouping followed a "preference-priority, random-supplement" strategy. Specifically: Patients with clear preferences were assigned to their chosen group; those without preferences were randomized 1:1 to either the conventional acupuncture group or the "Tongguan Liqiao" acupuncture group. Swallowing function served as the primary efficacy indicator to evaluate the clinical efficacy of different acupuncture intervention protocols for treating PSD.
Eligibility
Inclusion Criteria:
- 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.
- Meets diagnostic criteria for dysphagia, with FOIS grade 2-4;
- Meets diagnostic criteria for ischemic or hemorrhagic stroke, confirmed by CT or MRI, with disease duration within one year;
Exclusion Criteria:
- 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.
- Patients with an expected survival time of less than 3 months; ④ Individuals with contrast medium allergy;
- Patients with psychiatric disorders or severe cognitive impairment who cannot cooperate with treatment;
