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

16 juni 2026 bijgewerkt door: Xiaokai Chen, The Third People's Hospital of Huizhou

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: controlegroep
Ander: 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.
Experimenteel: The "Nine Needles for Swallowing" group
Apparaat: 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 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.
Actieve vergelijker: Tongue Three Needles Group
Apparaat: 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 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Oral Intake Scale
Tijdsspanne: 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.
Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Third People's Hospital of Huizhou

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 juni 2026

Primaire voltooiing (Geschat)

20 juni 2028

Studie voltooiing (Geschat)

20 december 2028

Studieregistratiedata

Eerst ingediend

10 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-KY-095-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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