Ultrasound-guided Fire Needle Acupuncture For Treating Sialorrhea In Tracheotomized Patients

Summary

Here, we present a protocol to apply fire needling under ultrasound guidance to the glandular or muscular layers for the treatment of sialorrhea in poststroke tracheotomized patients.

Abstract

Sialorrhea is a syndrome characterized by the overflow of saliva from the oral cavity, resulting from either hypersecretion of the salivary glands or dysphagia. As a common sequela in stroke patients, sialorrhea can induce feelings of low self-esteem, perioral and facial inflammation, aspiration pneumonia, and significantly increase healthcare costs. Current clinical management primarily relies on anticholinergic medications or botulinum toxin to inhibit saliva production. However, these treatments offer limited efficacy and are associated with adverse effects such as xerostomia and dysphagia. Consequently, non-pharmacological therapies, including acupuncture in traditional Chinese medicine and rehabilitation training, have emerged as effective alternatives. Fire needling, a traditional Chinese medicine technique, possesses dual properties: needle stimulation and a thermal effect. It is characterized by rapid operation, no needle retention, and transient pain. For patients with suboptimal response to pharmacotherapy, we developed an ultrasound-guided fire needling method to reduce salivary volume and salivation frequency while avoiding adverse effects. Details are described in the text. Ultrasound guidance allows preoperative visualization of muscular and glandular tissues and their surrounding structures, facilitating precise insertion of the fire needle into the targeted glandular or muscular layers, thereby optimizing treatment efficacy and safety.

Introduction

Stroke is characterized by significant clinical features of high incidence and high disability rates¹. Patients often experience varying degrees of respiratory insufficiency due to damage to the respiratory center or impairment of the respiratory conduction pathways. Among these, tracheotomy serves as a critical intervention for maintaining airway patency and supporting ventilation, and is widely applied in patients with severe stroke. According to research statistics, approximately 18.7% of stroke patients require this surgical procedure².

Sialorrhea, a common complication following stroke, typically results from dysphagia or autonomic dysregulation, leading to abnormal salivary secretion or impaired clearance, with consequent involuntary drooling³. Notably, in posttracheotomy patients, alterations in laryngeal anatomy and partial or complete loss of laryngeal function, when combined with sialorrhea, significantly increase the risk of silent aspiration and secondary aspiration pneumonia compared to sialorrhea patients without airway remodeling, thereby posing a more complex clinical challenge.

Current conventional treatments for sialorrhea primarily include anticholinergic medications, botulinum toxin injections, and surgical interventions. Although anticholinergic medications can improve salivary secretion to some extent, they may exacerbate autonomic dysregulation in stroke patients⁴. Botulinum toxin injections effectively reduce salivary secretion in most patients; however, their efficacy has a temporal limitation, requiring regular repeat injections to maintain therapeutic effects⁵. Surgical interventions, such as salivary gland duct transposition, ligation, or corresponding nerve severance, can achieve more sustained control of salivary secretion, but are associated with postoperative local pain and swelling, with poor tolerability in some patients⁶. Therefore, the development of safe and durable non-pharmacological therapies has gradually become an important research direction and clinical alternative in this field.

Research has demonstrated the advantages of acupuncture in treating post-stroke sialorrhea⁷. Fire needling, one of the traditional external therapies in Chinese medicine, was historically referred to as “brazing needling” or “burning needling” and is among the nine classical needling techniques. It possesses the dual properties of both needle stimulation and thermal effect. Existing studies have confirmed that fire needling can promote the proliferation of neural stem cells and their differentiation into neurons, thereby facilitating neural repair. Evidence also suggests that fire needling improves local blood circulation, dilates blood vessels, and regulates muscle tone. In addition, fire needling has been shown to modulate inflammatory and immune responses and improve the local metabolic environment. This technique uses a rapid pricking method with no needle retention, resulting in a short treatment duration⁸ and transient painful stimulation.

For patients who are not suitable candidates for pharmacological or botulinum toxin therapy, our team has developed an ultrasound-guided fire needling approach that precisely targets the glandular or muscular layers for the treatment of poststroke sialorrhea. The procedure is as follows: prior to fire needling, ultrasound is used to visualize the local anatomical structures at the acupoint. A puncture site that allows penetration into the muscle or gland while avoiding facial blood vessels is selected, marked, and the needling depth range is recorded. Fire needling is then performed. Compared with conventional methods, ultrasound guidance improves procedural precision and safety, offering a novel approach for the treatment of post-stroke sialorrhea.

Protocol

This protocol was approved by the Ethics Committee of the Fifth Affiliated Hospital of Guangzhou University of Chinese Medicine (Z202510-007-01). This study adopted a prospective, randomized controlled clinical trial design and involved patients from the Fifth Affiliated Hospital of Guangzhou University of Chinese Medicine. All participating patients provided informed consent.

1. Patient assessment

1. Inclusion criteria:
   1. Ensure that the patient meets the diagnostic criteria for cerebral hemorrhage or cerebral infarction as revised in the Diagnostic Criteria for Various Cerebrovascular Diseases established at the Fourth National Cerebrovascular Disease Academic Conference of the Chinese Medical Association (see Supplemental File 1)⁹.
   2. Assess the severity of sialorrhea using the Drooling Severity Scale (DSFS), and confirm that the patient has a DSFS score ≥ 3.
   3. Select patients with a retained tracheostomy tube equipped with a subglottic suction device and those aged between 18 and 70 years (inclusive), with no sex restriction.
2. Exclusion criteria:
   1. Exclude patients with sialorrhea attributable to other diseases or medications; who are unsuitable for fire needling; who have received botulinum toxin or anticholinergic medications (e.g., trihexyphenidyl) prior to trial initiation; and those with severe cardiac, hepatic, or renal insufficiency, severe electrolyte disturbances, or other serious systemic diseases.

2. Study design

1. Perform randomization of patients and blinding.
   1. Have an independent statistician generate the randomization sequence using statistical software. Assign subjects to the intervention and control groups in a 1:1 ratio.
   2. Maintain blinding of outcome assessors and data analysts throughout the study. Disclose grouping information only to the intervention administrator.
   3. Instruct outcome assessors to collect endpoint metrics without knowledge of group assignments. Complete all statistical analyses prior to unblinding.

3. Treatment

1. Provide standard secondary stroke prevention therapy to all patients¹⁰.
2. Conduct rehabilitation training, including swallowing and respiratory function exercises¹¹.
3. For the experimental group, implement conventional acupuncture and other traditional Chinese medicine treatments as per guidelines. Apply fire needle therapy to the experimental group.

4. Preoperative preparation

1. Prepare the following materials (Figure 1): ultrasound machine (Figure 1K), sterile ultrasound probe cover (Figure 1J), sterile coupling gel (Figure 1A), He-style fire needles (0.50 mm × 35 mm) (Figure 1D), alcohol lamp, 75% ethanol, lighter, disinfectant swabs (Figure 1B,C, E,F), masks, medical caps, and sterile gloves (Figure 1G-I).
2. Set up the treatment environment.
   1. Maintain a clean, quiet treatment room with controlled temperature and lighting. Minimize external light interference to ensure optimal probe coupling.
3. Patient preparation
   1. Obtain written informed consent from the patient after providing a thorough explanation of the procedure and the potential risks and benefits of the treatment.
   2. Raise the head of the bed to 45–90° and position the patient in a semirecumbent posture. When needling the cheek and mandible on one side, turn the patient’s head slightly to the contralateral side.
   3. Disinfect the needling point and the surrounding skin using a cotton swab containing 75% alcohol. Wait until the alcohol has completely evaporated and the skin is dry before proceeding with the operation.
      ​NOTE: During the procedure, ultrasound localization must be performed prior to fire needling. Keep the patient’s skin dry and clean before ultrasound localization. Before fire needling, disinfection is required, and the procedure should only be performed after the skin has dried.
4. Operator preparation
   1. Verify the patient’s basic information.
   2. Wash hands using the seven-step handwashing technique. Perform hand disinfection.
   3. Wear sterile gloves, a medical mask, and a surgical cap.
   4. Stand on the same side of the patient as the operative site.

5. Procedure

1. Select acupoints and needling sites.
   1. Locate acupoints according to the "Naming and Location of Meridian Acupoints" (GB/T 12346-2021)¹² (Figure 2).
      1. Locate Xiaguan (ST7) on the face; look for the depression located at the center of the lower edge of the zygomatic arch and between it and the mandibular notch.
      2. Locate Yifeng (SJ17) on the neck; look for the depression anterior to the mastoid process inferior, behind the earlobe.
      3. Locate the inferior Jiache point: on the face, locate the prominence of the masseter muscle when the jaw is clenched and the teeth are shut, and in a depression palpable when the muscle is relaxed; this is the Jiache (ST6). The Inferior Jiache Point is located directly inferior to Jiache (ST6), projecting to the depression on the medial aspect of the lower border of the mandible.
2. Ultrasound guidance and needling point localization
   1. Turn on the ultrasound system and press the Start-End button to initiate the examination.
   2. Press the Probe button and select the L15-4 linear array transducer.
   3. Press the Patient button and enter the patient’s name.
   4. Select the color Doppler mode.
   5. Localize the acupoints on one side of the face in the following order: Xiaguan (ST7), Yifeng (TE17), and the Inferior Jiache Point.
   6. Place the ultrasound transducer transversely with the probe marker positioned at Xiaguan (ST7). Move the ultrasound transducer horizontally to identify the local vascular course under ultrasound imaging.
      NOTE: The following structures are visualized: skin, subcutaneous tissue, parotid gland (visible in some patients), and masseter muscle (Figure 3A,B).
   7. Define the needle insertion points on the skin surface at Xiaguan (ST7) and 0.5 cm lateral to it on both sides horizontally. To target the masseter muscle layer, select an appropriate needling depth while avoiding blood vessels. Press the measurement button to measure the needling depth range. Mark the superficial needle insertion point on the skin and record the needling depth.
   8. Place the ultrasound transducer longitudinally with the probe marker positioned at Yifeng (TE17). Move the ultrasound transducer vertically to identify the local vascular course under ultrasound imaging.
      NOTE: The following structures are visualized: skin, subcutaneous tissue, and parotid gland (Figure 3C,D).
   9. Define the needle insertion points on the skin surface at Yifeng (TE17) and 0.5 cm superior and inferior to it vertically. To target the parotid gland layer, select an appropriate needling depth while avoiding blood vessels. Press the measurement button to measure the needling depth range. Mark the superficial needle insertion point on the skin and record the needling depth.
   10. Localize the Inferior Jiache Point and the surrounding needling points. Place the ultrasound transducer transversely with the probe marker positioned at the Inferior Jiache Point. Move the ultrasound transducer horizontally to identify the local vascular course under ultrasound imaging.
       NOTE: The following structures are visualized: skin, subcutaneous tissue, and submandibular gland (Figure 3E,F).
   11. Define the needle insertion points on the skin surface at the Inferior Jiache Point and 0.5 cm lateral to it on both sides horizontally. To target the submandibular gland layer, select an appropriate needling depth while avoiding blood vessels. Press the measurement button to measure the needling depth range. Mark the superficial needle insertion point on the skin and record the needling depth.
       NOTE: During fire needling, perform the needling procedure directly at the marked points at the predetermined depth, without reliance on ultrasound guidance intraoperatively.
   12. Localize the acupoints on the contralateral side using the same method.
3. Fire needling procedure
   1. Perform preoperative disinfection using medical alcohol.
      NOTE: Wait until the alcohol has evaporated and the skin is dry before proceeding with the operation.
   2. Perform fire needling on one side of the face and mandible in the following order: Xiaguan (ST7), Yifeng (TE17), and the Inferior Jiache Point.
      1. Heat the tip of the fire needle in the outer flame of an alcohol lamp until it glows red to white-hot¹³, then rapidly and perpendicularly insert it into the acupoint and the surrounding needling points to the predetermined depth.
         NOTE: Heating the fire needle to white-hot takes approximately 8–10 s, reaching a temperature of approximately 700–800 °C. The insertion depth of the fire needle should fall within the measured depth range, varying according to the patient’s measurements. If the operator is not proficient in controlling the needling depth, use a fire needling gun.
      2. After pricking, instruct the assistant to gently press the needle hole with a clean dry cotton ball to prevent infection.
      3. After completing fire needling on one side, have both operator and assistant move to the contralateral side and needle the opposite side of the face and mandible using the same method.
   3. Administer treatment 2x per week, with one course consisting of 7 days, and deliver two courses of treatment. Perform fire needling on days 1 and 4 of each course.
4. Posttreatment care
   1. Instruct the patient and their family members to avoid water exposure on the treated area within 24 h after treatment. If cleaning is necessary, gently wipe the surrounding area with a sterile cotton swab dipped in a small amount of normal saline or iodophor.
   2. Inform the patient and their family members that mild redness, swelling, heat, and pain after treatment are normal phenomena and usually resolve spontaneously within 1–3 days. Itching may occur during the scabbing process after fire needling; do not scratch the area; allow the scab to fall off naturally.
   3. If any other discomfort occurs, promptly inform the attending physician.

6. Prevention of adverse events

1. Preventive measures
   1. Before the study, ensure adequate communication with the patient and their family members, and provide a detailed explanation of the treatment procedure and necessary precautions.
   2. Record all adverse reactions and their duration occurring during the treatment period, including pain, skin reactions, and burns.
2. Possible adverse events and countermeasures
   1. If burns occur, rinse the injured area with a large amount of running cold water for 15–20 min to reduce skin temperature. Apply burn ointment and cover with sterile gauze to prevent infection. For deep burns or large-area burns, promptly refer the patient to the burn department.
   2. If bleeding and hematoma occur, apply continuous pressure to the bleeding point with a dry cotton ball; bleeding usually stops within a few minutes. If a hematoma forms, apply cold compresses within 24 h; after 24 h, switch to warm compresses to promote resolution of the ecchymosis.
   3. If severe pain occurs, stop needling, allow the patient to rest briefly, and decide whether to continue after the patient has calmed down. Confirm whether the pain is caused by insufficient heating of the needle tip.
   4. If infection occurs, apply topical antibiotic ointment for mild cases. For severe infections, oral or intravenous antibiotics are required. If an abscess has formed, have a surgeon perform incision and drainage.

7. Efficacy assessment

1. Primary outcome measures
   1. Assess the patient’s sialorrhea status before and after treatment using the Drooling Severity and Frequency Scale (Table 1)¹⁴.
   2. Measure the patient’s unstimulated salivary flow rate before and after treatment.
      1. Before measurement, have an assistant or family member assist the patient to a sitting position with the head of the bed raised to 90°, and clean the patient’s oral cavity of saliva using a medical cotton swab.
      2. Have the operator place the medical swab on a high-precision milligram electronic scale and record its dry weight.
      3. Place the swab on both buccal mucosa and sublingual areas of the patient. After 5 min, remove the swab and weigh it again to obtain the wet weight.
      4. Calculate the difference between the wet and dry weights, and compute the salivary flow rate¹⁵ (unit: g/min).
2. Secondary outcome measure
   1. Assess the patient’s subglottic secretion aspirate volume over 1 h before and after treatment.
      1. Before the procedure, use a syringe to aspirate subglottic saliva from the patient until no more can be withdrawn.
      2. One hour later, again use a syringe to aspirate subglottic saliva from the patient until no more can be withdrawn, and record the fluid volume.

Drooling Severity Scale(DSFS-S)	clinical manifestation
1-Dry	Never drools
2-Mild	Only lips wet
3-Moederate	Wet on lips and chin
4-Severe	Drool extends to clothes wet
5-Profues	Clothing,hands,tray,and objects wet
Drooling Severity Scale(DSFS-F)
1-Never
2-Occasionally	Not every day
3-Frequently	Part of every day
4-Constantly

Table 1: Drooling severity and frequency scale.

8. Statistical analysis

1. Perform all statistical analyses using professional statistical analysis and graphing software.
2. Express continuous data as mean ± standard deviation; express count data as frequencies (n) or percentages (%); describe ordinal data using frequencies and constituent ratios.
3. Use the two independent samples t-test to compare pre- and post-treatment changes in continuous data between the two groups; use the Mann-Whitney U rank sum test to compare pre- and post-treatment differences in ordinal data between the two groups.
4. Set the significance level α = 0.05, and consider P ≤ 0.05 as statistically significant.

Results

This protocol describes a randomized controlled study investigating the efficacy and safety of fire needling in improving sialorrhea in stroke patients. A total of 40 tracheotomized patients diagnosed with poststroke sialorrhea were enrolled, of whom 20 received fire needling. Individual and total scores before and after treatment were analyzed, including DSFS, uSFR, and SAV-1h.

Analysis of DSFS scores between the control and the experimental groups showed no significant difference before trea...

Discussion

Sialorrhea is one of the common complications following stroke, which can severely affect the patient’s self-image, daily life, and social interactions, and may even lead to feelings of inferiority and significant psychological stress. Poststroke sialorrhea can result from both primary and secondary factors. Autonomic dysregulation after stroke may cause primary hypersalivation. It may also affect the six pairs of cranial nerves involved in swallowing within the brainstem, thereby inducing dysphagia and leading to ...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Alcohol lamp	wevola
Ethanol disinfectant	Guangdong Province Guangning County Glucose Pharmaceutical Co., Ltd.
Fire needle	Zhenjiang New District Great Wall Medical Supplies Factory
Lighter	Zhejiang Da Hu Lighter Factory Co., Ltd.
Medical cap	Henan Jianhe Industrial Co., Ltd.
Medical cotton swabs	Henan Kanglujian Medical Co., Ltd.
Medical gloves	Steady Medical Products Co., Ltd.
Medical mask	Hao Zheng Xieqi
Medical ultrasound coupling agent	Guangzhou Guanggong Technology Development Co., Ltd.
Sterile ultrasound probe cover	Suzhou Angfilin Materials Technology Co., Ltd.
Ultrasound machine	Shenzhen Huasheng Medical Technology Co., Ltd.		Wisonic Clover60 color Doppler ultrasound system with L15-4 linear array probe