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

NCT07656025 | Not Yet Recruiting

• 1 other identifier: 2026-KY-095-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acupuncture; Dysphagia; Surface EMG

Keywords

Stroke; Dysphagia; Nine needles for swallowing; Acupuncture; Clinical research; mechanism

Outcome Measures

Primary Outcomes (1)

• Functional Oral Intake Scale

  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

Secondary Outcomes (7)

• Standardized Swallowing Assessment score

  Baseline period, 1 week after intervention, 2 weeks after intervention

• Leakage aspiration score

  Baseline and intervention 2 weeks later

• Video perspective swallowing examination

  Baseline and intervention 2 weeks later

• water swallow test

  Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up

• Mid arm circumference

  Baseline and intervention 2 weeks later

Study Arms (3)

The "Nine Needles for Swallowing" group

EXPERIMENTAL

Device: Yanjiu Acupuncture

Tongue Three Needles Group

ACTIVE COMPARATOR

Device: a three-point acupuncture technique

control group

OTHER

Other: control group

Interventions

Yanjiu Acupuncture DEVICE

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.

The "Nine Needles for Swallowing" group

a three-point acupuncture technique DEVICE

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.

Tongue Three Needles Group

control group OTHER

The control group received conventional medical treatment combined with routine rehabilitation training. No additional acupuncture intervention was provided during the 2-week observation period.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third People's Hospital of Huizhou: lead
• Guangdong Province, Department of Science and Technology: collaborator
• Tianjin University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Meilian Lai

CONTACT

13074223663; 1141406341@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Acupuncture

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 18, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share