Acupuncture for post-stroke swallowing problems

Acupuncture Treatment for Post-Stroke Dysphagia: A Prospective, Multicenter Clinical Study of a Cohort-Based Embedded Partially Randomized Preference Trial

This project tests whether different acupuncture approaches improve swallowing in adults with post-stroke dysphagia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3232 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07493902 on ClinicalTrials.gov

What this trial studies

The design nests a partially randomized preference trial within a prospective multicenter cohort to compare acupuncture protocols for post-stroke dysphagia. In the cohort portion, acupuncture exposure forms natural groups to study real-world effectiveness and health-economic outcomes of integrated Chinese–Western treatments. In the embedded partially randomized preference trial, patients without a strong treatment preference are randomized 1:1 to conventional acupuncture or a Tongguan Liqiao protocol, while those with clear preferences are assigned to their chosen group. Primary outcomes focus on swallowing function with subgroup analyses and cost-effectiveness measured across participating centers from January 2026 to December 2027.

Who should consider this trial

Good fit: Adults 18–80 with ischemic or hemorrhagic stroke within one year, clinically confirmed dysphagia (FOIS grade 2–4), stable vital signs, and ability to consent or having a legal representative to consent.

Not a fit: Patients with dysphagia from non-stroke causes, severe cognitive or psychiatric impairment preventing cooperation, expected survival under three months, severe needle phobia, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could identify acupuncture protocols that improve swallowing and help guide treatment choices for people with post-stroke dysphagia.

How similar studies have performed: Previous small trials and meta-analyses have suggested acupuncture can help post-stroke dysphagia, but high-quality randomized evidence is limited, so this work builds on promising but not definitive data.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin Municipality

• Xiaonong Fan — Tianjin, Tianjin Municipality, China (RECRUITING)

Conditions: Post-stroke Dysphagia, Acupuncture, post-stroke dysphagia, acupuncture