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

Sponsor
The Third People's Hospital of Huizhou
Study ID
NCT07656025
Status
Not Yet Recruiting

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Conditions

  • Acupuncture
  • Dysphagia
  • Surface EMG

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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 The needles were slowly inserted toward the root of the tongue to a depth of approximately 1.5 cun and were withdrawn immediately without needle retention.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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 20, 2026
Status verified
Jun 2026
Primary completion
Jun 20, 2028
Completion
Dec 20, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: The "Nine Needles for Swallowing" group
  • Active Comparator: Tongue Three Needles Group
  • Other: control group

Primary Outcome Measure

Functional Oral Intake Scale [ Time Frame: Baseline period, 1 week after intervention, 2 weeks after intervention, and at the 4th week follow-up ]

Central Contacts

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