Efficacy and Mechanism of 'Yanjiu Needle' for Pharyngeal Dysphagia Based on sEMG Features
16 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Meilian Lai
- Numero di telefono: 13074223663
- Email: 1141406341@qq.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: gruppo di controllo
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The control group received conventional medical treatment combined with routine rehabilitation training.
No additional acupuncture intervention was provided during the 2-week observation period.
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Sperimentale: The "Nine Needles for Swallowing" group
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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.
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Comparatore attivo: Tongue Three Needles Group
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Functional Oral Intake Scale
Lasso di tempo: 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.
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Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Standardized Swallowing Assessment score
Lasso di tempo: Baseline period, 1 week after intervention, 2 weeks after intervention
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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.
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Baseline period, 1 week after intervention, 2 weeks after intervention
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Leakage aspiration score
Lasso di tempo: Baseline and intervention 2 weeks later
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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.
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Baseline and intervention 2 weeks later
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Video perspective swallowing examination
Lasso di tempo: Baseline and intervention 2 weeks later
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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.
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Baseline and intervention 2 weeks later
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water swallow test
Lasso di tempo: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up
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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
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Mid arm circumference
Lasso di tempo: Baseline and intervention 2 weeks later
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Baseline and intervention 2 weeks later
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Surface electromyography examination
Lasso di tempo: Baseline and intervention 2 weeks later
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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.
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Baseline and intervention 2 weeks later
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Mini Nutritional Assessment-Short Form (MNA-SF)
Lasso di tempo: Baseline and intervention 2 weeks later
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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.
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Baseline and intervention 2 weeks later
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
20 giugno 2026
Completamento primario (Stimato)
20 giugno 2028
Completamento dello studio (Stimato)
20 dicembre 2028
Date di iscrizione allo studio
Primo inviato
10 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 giugno 2026
Primo Inserito (Effettivo)
18 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie esofagee
- Malattie otorinolaringoiatriche
- Malattie faringee
- Ictus
- Disturbi della deglutizione
- Tecniche investigative
- Progetto di ricerca epidemiologica
- Metodi epidemiologici
- Progetto di ricerca
- Metodi
- Gruppi di controllo
Altri numeri di identificazione dello studio
- 2026-KY-095-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .