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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
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.
The control group received conventional medical treatment combined with routine rehabilitation training. No additional acupuncture intervention was provided during the 2-week observation period.
Functional Oral Intake Scale
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.
Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up
Standardized Swallowing Assessment score
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.
Time frame: Baseline period, 1 week after intervention, 2 weeks after intervention
Leakage aspiration score
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.
Time frame: Baseline and intervention 2 weeks later
Video perspective swallowing examination
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.
Time frame: Baseline and intervention 2 weeks later
water swallow test
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.
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
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.
Time frame: Baseline and intervention 2 weeks later
Mini Nutritional Assessment-Short Form (MNA-SF)
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.
Time frame: Baseline and intervention 2 weeks later
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