Complementary Acupuncture Treatment of Dysphagia in Stroke

China Medical University

Status: Enrolling

Conditions: Stroke

Treatments: Other: Sham control group II; Other: Sham control group I; Other: Verum acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT05429424

CMUH111-REC1-065

Details and patient eligibility

About

A Taiwanese study pointed out that stroke patients who have language barriers, dysphagia, and aspiration pneumonia are more likely to suffer from prolonged hospitalization. Improvements in dysphagia and subsequent complications in patients should be effective in reducing hospital stays and improving the quality of long-term care. In view of clinical medical needs and policy trends, this study aims to explore the efficacy of using traditional Chinese medicine to treat cerebral apoplexy sequelae in Taiwan. It is expected that through (1) exploration of real-world data analysis, combined with the advantages of Taiwan's biomedical database, data exploration will be carried out to provide big data (2) Multi-center prospective randomized clinical trials, providing clinical evidence of the highest level of evidence in empirical medicine.

Enrollment: 336 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• .Patients aged more than 20 years

• The diagnosis of first stroke was established within the six months

• Patients had a score ≥ 25 of Mini-Mental State Examination (MMSE)

• Patients met one or both indications as follows

  1. Dysphagia confirmed under the standardized swallowing assessment
  2. Nasogastric tube feeding already

Exclusion criteria

• Previous history of swallowing disability
• Currently known coagulopathy leading to bleeding disorder.
• Previous surgery of head or neck
• Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
• Psychological or behavior disorder
• Currently pregnant or breastfeeding women.
• Previous acupuncture treatment for any indication within 30 days of enrollment.
• Severe chronic or uncontrollable complications interference the processing of the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 3 patient groups

Verum acupuncture group

Experimental group

Description:

The study uses manual acupuncture as verum intervention.

Treatment:

Other: Verum acupuncture group

Sham control group I

Sham Comparator group

Description:

The study used specific made needle with a blunt tip, Streitberger device, as sham intervention.

Treatment:

Other: Sham control group I

Sham control group II

Sham Comparator group

Description:

Manual acupuncture at the points unrelated to the dysphagia is another sham intervention in this study.

Treatment:

Other: Sham control group II