Efficacy and Mechanism of 'Yanjiu Needle' for Pharyngeal Dysphagia Based on sEMG Features
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorThe Third People's Hospital of Huizhou
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Yanjiu Acupuncture
DeviceParticipants 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
DeviceParticipants 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 interventionThe control group received conventional medical treatment combined with routine rehabilitation training. No additional acupuncture intervention was provided during the 2-week observation period.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: The "Nine Needles for Swallowing" groupExperimental treatment 1 intervention
Group B: Tongue Three Needles GroupActive comparator 1 intervention
Group C: control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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 intervention2
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 later3
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 later4
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-upLocations
Sponsors and contacts
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The Third People's Hospital of Huizhou
Lead sponsor
Tianjin University of Traditional Chinese Medicine
Collaborator
Guangdong Province, Department of Science and Technology
Collaborator
Source ClinicalTrials.gov
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