Efficacy and Mechanism of 'Yanjiu Needle' for Pharyngeal Dysphagia Based on sEMG Features
16. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Meilian Lai
- Telefonní číslo: 13074223663
- E-mail: 1141406341@qq.com
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Jiný: kontrolní skupina
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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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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Oral Intake Scale
Časové okno: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Standardized Swallowing Assessment score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline and intervention 2 weeks later
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Baseline and intervention 2 weeks later
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Surface electromyography examination
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
20. června 2026
Primární dokončení (Odhadovaný)
20. června 2028
Dokončení studie (Odhadovaný)
20. prosince 2028
Termíny zápisu do studia
První předloženo
10. června 2026
První předloženo, které splnilo kritéria kontroly kvality
16. června 2026
První zveřejněno (Aktuální)
18. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Nemoci jícnu
- Otorinolaryngologická onemocnění
- Faryngeální onemocnění
- Mrtvice
- Poruchy deglutace
- Vyšetřovací techniky
- Epidemiologický výzkumný návrh
- Epidemiologické metody
- Návrh výzkumu
- Metody
- Kontrolní skupiny
Další identifikační čísla studie
- 2026-KY-095-01
Plán pro data jednotlivých účastníků (IPD)
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NE
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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