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

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.

Study Overview

• Status: Recruiting
• Conditions: Acupuncture; Post-stroke Dysphagia
• Intervention / Treatment: Procedure: acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 3232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300193
      • Recruiting
      • Xiaonong Fan
      • Contact: Xiaonong Fan, PhD; Phone Number: 13902080823; Email: fanxiaonong@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Tongguan Liqiao" Acupuncture Group; The Tongguan Liqiao acupuncture technique developed by Academician Xuemin Shi is employed. The procedure follows the SCM 88-2025 International Standard for Traditional Chinese Medicine Techniques: Tongguan Liqiao Acupuncture for PSD.	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.
Active Comparator: Conventional Acupuncture Group; Each research unit (sub-center) shall strictly adhere to the "protocol plan" designated for routine use. Once specified, the protocol plan shall not be altered and must be executed in strict accordance with its provisions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respondent proportion	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.	Days 1-14

Collaborators and Investigators

• Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; post-stroke dysphagia
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: TYLL2026[K]007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No