Acupuncture, Post-stroke Dysphagia
Conditions
Keywords
post-stroke dysphagia, acupuncture
Brief 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.
Detailed 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.
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.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Due to the unique nature of acupuncture clinical research, achieving double-blind conditions for both subjects and practitioners is challenging in the non-preference group of Study 2. Therefore, this trial employed single-blind conditions for subjects and statisticians only.
Intervention model description
This study employs a nested design comprising two components. Study 1 (Main Cohort): A prospective, multicenter cohort study. Patients with post-stroke dysphagia enrolled from January 2026 to December 2027 will be stratified into an "acupuncture cohort" and a "non-acupuncture cohort" based on actual clinical exposure to acupuncture. Total enrollment: 3,232 patients. Study 2 (Nested Study): A prospective, multicenter, partially randomized preference trial nested within Study 1, targeting patients with explicit acupuncture preferences. It employs a "preference-priority, random-supplementation" strategy: Patients with clear preferences are enrolled in their chosen "conventional acupuncture" or "acupuncture for Tongguan Liqiao" group; patients without clear preferences are randomly assigned 1:1 to either group. Approximately 230 patients without clear preferences will be recruited.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respondent proportion | Days 1-14 | Collect FOIS grading data at multiple time points. Proportion of patients showing an improvement of 2 grades or more in FOIS from baseline after treatment. |
Countries
China
Outcome results
None listed