Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07493902

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

Led by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Updated on 2026-03-25

3232

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying post-stroke dysphagia (difficulty swallowing after a stroke) by examining the effects of acupuncture treatments. This study uses a nested design with two parts: a prospective multicenter cohort study and an embedded partially randomized preference trial. The goal is to evaluate the clinical efficacy and health economic value of different acupuncture protocols combined with Western medicine, aiming to provide evidence-based guidance for treating this condition. The study includes two acupuncture approaches. One group receives the "Tongguan Liqiao" acupuncture method, following international and national standards for point selection and operation. The other group receives conventional acupuncture protocols specific to each research center. Patients with a preference for one method choose that group, while those without preference are randomly assigned to either group. Treatments focus on specific acupuncture points and follow strict protocols that cannot be altered once set. Participants will be enrolled between April 2026 and December 2027 and followed through the treatment period. Researchers will assess swallowing function as the primary outcome, measuring the proportion of participants responding to treatment within 14 days. Patients' vital signs, ability to cooperate, and overall health will be monitored. The study emphasizes both clinical effects and the economic value of integrating acupuncture with Western medical treatments for post-stroke dysphagia.

CONDITIONS

Brief Title

Acupuncture for Post-Stroke Dysphagia: A Clinical Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old, no gender restrictions
  • Diagnosis of ischemic or hemorrhagic stroke confirmed by CT or MRI, with disease duration within one year
  • Diagnosed with dysphagia, with Functional Oral Intake Scale (FOIS) grade 2-4
  • Stable vital signs and able to understand and cooperate with study procedures
  • Patient or legal representative agrees to sign informed consent
Not Eligible

You will not qualify if you...

  • Dysphagia caused by neurological disorders other than stroke or by organic lesions such as tumors
  • Psychiatric disorders or severe cognitive impairment preventing cooperation with treatment
  • Expected survival time less than 3 months
  • Allergy to contrast medium
  • Severe needle phobia preventing tolerance of acupuncture
  • Pregnant, planning pregnancy, or lactating women
  • Participation in other clinical trials or acupuncture treatment within the past week

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 weeks

Participants receive acupuncture treatment for post-stroke dysphagia using either the Tongguan Liqiao technique or conventional acupuncture protocols.

Multiple visits during treatment period as per protocol

Trial Site Locations

Total: 1 location

1

Xiaonong Fan

Tianjin, Tianjin Municipality, China, 300193

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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