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

16 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: grupo de controle
Outro: 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.
Experimental: The "Nine Needles for Swallowing" group
Dispositivo: 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.
Comparador Ativo: Tongue Three Needles Group
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Functional Oral Intake Scale
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Standardized Swallowing Assessment score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline and intervention 2 weeks later
Baseline and intervention 2 weeks later
Surface electromyography examination
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Third People's Hospital of Huizhou

Colaboradores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

20 de junho de 2026

Conclusão Primária (Estimado)

20 de junho de 2028

Conclusão do estudo (Estimado)

20 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

18 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-KY-095-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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