NCT07493902

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,232 (estimated)
• Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-stroke Dysphagia
• Acupuncture

Interventions

Type	Name	Description
PROCEDURE	acupuncture	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China