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NCT07656025
Efficacy and Mechanism of 'Yanjiu Needle' for Pharyngeal Dysphagia Based on sEMG Features
Conditions: Acupuncture, Dysphagia, Surface EMG
Sex: All
Ages: 40 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: The Third People's Hospital of Huizhou
Summary
Dysphagia is one of the most common and serious complications following stroke. It can easily lead to aspiration and aspiration pneumonia, reduce patients' quality of life, increase healthcare costs, and result in high mortality rates, making it a clinical issue that urgently needs to be addressed. Current mainstream therapies have limitations: neurostimulation targets a single pathway, while rehabilitation training offers only limited improvement in microcirculation and suffers from low patient compliance. Although acupuncture shows promise, it lacks high-quality randomized controlled evidence, and the specific acupuncture techniques lack standardized operational protocols, limiting their widespread adoption. In preliminary clinical practice, Chen Xiaokai, a renowned traditional Chinese medicine practitioner in Guangdong Province, developed the "Nine Pharyngeal Acupoints" (including Lianquan and Renying) based on the "resolving knots" theory. This approach can rapidly improve pharyngeal muscle tone and swallowing function. Basic research has confirmed that stimulation of these acupoints promotes pharyngeal circulation, activates the brainstem, and aids in the restoration of the swallowing reflex. This study aims to conduct a single-center, assessor-blinded, randomized, controlled, prospective superiority clinical trial. Using surface electromyography (EMG) as the core assessment tool, combined with swallowing videofluoroscopy and functional scales, the study will analyze the efficacy and neuro-muscular regulatory mechanisms of the "Nine Pharyngeal Acupoints" technique. The study is expected to clarify its therapeutic efficacy, establish standard operating procedures, and provide a basis for clinical implementation.
Eligibility Criteria
Inclusion Criteria:
* First onset of stroke with swallowing disorders lasting for 2 weeks to 6 months;
* Stable vital signs, able to understand and execute physician instructions, and cooperate with treatment;
* Age range: 40-75 years old, male or female not limited;
* Functional Oral Intake Scale (FOIS) classification ≤ 4;
* The patient's surgical site can receive acupuncture treatment;
* Informed consent from patients or family members.
Exclusion Criteria:
* Individuals with unstable vital signs who are unable to complete assessment and treatment;
* Individuals with severe cognitive impairment, communication barriers, or other mental illnesses who are unable to cooperate with treatment;
* Individuals with a history of oral, pharyngeal, and esophageal structural abnormalities, cricopharyngeal muscle stenosis, and cancer;
* Confirmed by cranial CT/MRI as a deceased with brainstem infarction/hemorrhage and extensive cerebral infarction;
* Participants in other clinical trials;
* Those who cannot accept surface electromyography examination; Pregnant and lactating women.
Source: ClinicalTrials.gov (NCT07656025). StuddyBuddy aggregates publicly available trial information.