Efficacy and Mechanism of 'Yanjiu Needle' for Pharyngeal Dysphagia Based on sEMG Features

Official title

Therapeutic Efficacy and Mechanistic Study of Yanjiu Acupuncture in Patients With Pharyngeal Dysphagia Based on Surface Electromyographic Features

Overview

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.

Interventions

• Device Yanjiu Acupuncture
  Participants in this group received conventional medical treatment and rehabilitation training combined with Yanjiu Acupuncture therapy.Acupuncture was performed at Lianquan (CV23), bilateral Extra-Hyoid points, bilateral Renying (ST9), bilateral Shangrenying points, and bilateral Xiarenying points. Disposable sterile stainless-steel acupuncture needles (Huatuo brand, Suzhou Medical Appliance Factory, Suzhou, China; 0.35 × 40 mm) were used. Patients were placed in the supine position, and the ac
• Device a three-point acupuncture technique
  Participants in this group received conventional medical treatment and rehabilitation training combined with She San Zhen acupuncture (a three-point acupuncture technique). The acupuncture points included Lianquan (CV23) and bilateral Jia Lianquan (extra points). Disposable sterile stainless-steel acupuncture needles (Huatuo®, Suzhou Medical Appliance Factory, Suzhou, China; 0.35 × 40 mm) were used. With the participant in the supine position, the acupoints were routinely disinfected prior to ne
• Other control group
  The control group received conventional medical treatment combined with routine rehabilitation training. No additional acupuncture intervention was provided during the 2-week observation period.

Primary outcome measures

• Functional Oral Intake Scale [Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up]

Secondary outcome measures (7)

• Standardized Swallowing Assessment score [Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention]
• Leakage aspiration score [Time frame: Baseline and intervention 2 weeks later]
• Video perspective swallowing examination [Time frame: Baseline and intervention 2 weeks later]
• water swallow test [Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up]
• Mid arm circumference [Time frame: Baseline and intervention 2 weeks later]
• Surface electromyography examination [Time frame: Baseline and intervention 2 weeks later]
• Mini Nutritional Assessment-Short Form (MNA-SF) [Time frame: Baseline and intervention 2 weeks later]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07656025 · 2026-KY-095-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗