Acupuncture for Post-Stroke Dysphagia: A Clinical Study

NCT07493902 | Recruiting DMC

• 1 other identifier: TYLL2026[K]007
• Study Type: interventional
• Target: 3,232
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Dysphagia; Acupuncture

Keywords

post-stroke dysphagia; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

"Tongguan Liqiao" Acupuncture Group

EXPERIMENTAL

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

Conventional Acupuncture Group

ACTIVE COMPARATOR

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

Interventions

acupuncture PROCEDURE

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.

"Tongguan Liqiao" Acupuncture Group; Conventional Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xiaonong Fan

Tianjin, Tianjin Municipality, 300193, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)