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

16 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: kontrollgrupp
Övrig: 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.
Experimentell: The "Nine Needles for Swallowing" group
Enhet: 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.
Aktiv komparator: Tongue Three Needles Group
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Oral Intake Scale
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Standardized Swallowing Assessment score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and intervention 2 weeks later
Baseline and intervention 2 weeks later
Surface electromyography examination
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Third People's Hospital of Huizhou

Samarbetspartners

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

20 juni 2026

Primärt slutförande (Beräknad)

20 juni 2028

Avslutad studie (Beräknad)

20 december 2028

Studieregistreringsdatum

Först inskickad

10 juni 2026

Först inskickad som uppfyllde QC-kriterierna

16 juni 2026

Första postat (Faktisk)

18 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-KY-095-01

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