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NCT Number: NCT07656025

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

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.

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Key information

Conditions

Acupuncture Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Surface EMG Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yanjiu Acupuncture

Device

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 acupoints were routinely disinfected before needle insertion. After obtaining Deqi, a balanced reinforcing-reducing manipulation (Ping Bu Ping Xie) was applied by twirling the needles for approximately 30 seconds, with a rotation angle of 90°-180° and a frequency of 60-80 rotations per minute. Treatment was administered once daily, five sessions per week, for two consecutive weeks. The needles were removed immediately after manipulation without retention.

a three-point acupuncture technique

Device

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 needle insertion. The needles were slowly inserted toward the root of the tongue to a depth of approximately 1.5 cun and were withdrawn immediately without needle retention. The intervention was administered once daily, five sessions per week, for two consecutive weeks.

Control Group

Other

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 outcomes

  1. Functional Oral Intake Scale

    Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up

    The Functional Oral Intake Scale (FOIS) is a clinical tool used to assess a patient's oral feeding ability, particularly in individuals with dysphagia or those requiring monitoring of swallowing and feeding function. The FOIS classifies oral intake into seven levels, ranging from Level 1 (nothing by mouth) to Level 7 (total oral diet with no restrictions). Higher scores indicate better functional oral intake ability.

Secondary outcomes

  1. Standardized Swallowing Assessment score

    Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention

    The Standardized Swallowing Assessment (SSA) consists of three sequential steps. The first step involves a clinical examination, followed by the administration of 5 mL of water three times. In the second stage, if swallowing in the first stage is assessed as normal, the patient is given 60 mL of water in a cup. The SSA score ranges from 17 to 46, with higher scores indicating more severe swallowing impairment.

  2. Leakage aspiration score

    Time frame: Baseline and intervention 2 weeks later

    Used during videofluoroscopic swallowing study (VFSS) to evaluate a subset of enrolled patients, this scale assesses the presence and severity of penetration and aspiration. The Penetration-Aspiration Scale (PAS) ranges from 1 to 8, with higher scores indicating more severe penetration and aspiration. A PAS score ≥5 is defined as aspiration.

  3. Video perspective swallowing examination

    Time frame: Baseline and intervention 2 weeks later

    Each patient was confirmed and evaluated using X-ray imaging techniques, which were also used to assess swallowing function before and after treatment in a subset of patients, including pharyngeal motion and bolus transit. Patients were administered barium sulfate only after confirming the absence of aspiration. Fluoroscopic imaging was used to observe the direction of barium flow, the degree and speed of contraction, esophageal peristalsis, pharyngeal activity, the piriform sinus, and the presence of residual material.

  4. water swallow test

    Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up

    The patient was seated upright and asked to swallow 30 mL of warm water. The time required for swallowing and the presence of coughing or choking were recorded.

    Grade 1 (Excellent):The patient was able to swallow the water smoothly in a single attempt.

    Grade 2 (Good):The patient swallowed the water in two or more attempts without coughing or choking.

    Grade 3 (Moderate): The patient swallowed the water in a single attempt but with coughing or choking.

    Grade 4 (Fair):The patient swallowed the water in two or more attempts with coughing or choking.

    Grade 5 (Poor): The patient experienced frequent coughing or choking and was unable to swallow the entire volume.

  5. Mid arm circumference

    Time frame: Baseline and intervention 2 weeks later

  6. Surface electromyography examination

    Time frame: Baseline and intervention 2 weeks later

    sEMG assessments will be performed before and after treatment (at baseline and 2 weeks post-treatment). Surface electromyographic signals of the mylohyoid-suprahyoid muscle complex will be recorded. sEMG signals will be collected during both dry swallowing and swallowing of 5 mL of warm water. The mean sEMG amplitude and average swallowing duration will be recorded. After each swallow, a 3-minute rest period will be allowed, and the test will be repeated three times, with the average value used for analysis. Higher values indicate better swallowing function.

  7. Mini Nutritional Assessment-Short Form (MNA-SF)

    Time frame: Baseline and intervention 2 weeks later

    The Mini Nutritional Assessment-Short Form (MNA-SF) is a validated screening tool designed to identify older adults who are malnourished or at risk of malnutrition. It is widely used in clinical and research settings due to its simplicity, rapid administration, and good sensitivity.The MNA-SF consists of six items assessing appetite and food intake, recent weight loss, mobility, psychological stress or acute disease, neuropsychological problems, and body mass index (BMI) or calf circumference when BMI is unavailable. The total score ranges from 0 to 14, with higher scores indicating better nutritional status. Based on the score, individuals are classified as normal nutritional status, at risk of malnutrition, or malnourished.

Study contacts

Contact information is provided by the study sponsor or research team.

Meilian Lai

CONTACT

[email protected]

13074223663

Sponsors and collaborators

Lead sponsor

The Third People's Hospital of Huizhou

Other

Collaborators

  • Guangdong Province, Department of Science and Technology
  • Tianjin University of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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