A Study of Artificial Intelligence-Assisted Visualization-Guided Acupuncture at the "Xinwu Point" for Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Needling success rate
研究概览
简要总结
This study evaluated a new way to perform acupuncture at a deep point called the Xinwu point (sphenopalatine ganglion) for allergic rhinitis (hay fever-like nasal allergy). The point is hard to reach with the usual blind needling method. Artificial intelligence (AI) with real-time ultrasound images was used to help the acupuncturist see nearby structures and guide the needle. Sixty adults were randomly assigned to AI-guided needling or usual blind needling. Both groups received the same acupuncture schedule: both sides of the face, once a week, for six sessions. The primary aim was to measure how accurately the needle reached the target. Side effects, nasal symptom scores, overall improvement, and how acceptable participants found the procedure were also recorded.
详细描述
This was a single-center, parallel-group, randomized controlled trial conducted at Daxing Teaching Hospital of Capital Medical University (Beijing Daxing District People's Hospital), China, from September 2025 to May 2026.
Participants: 60 adults aged 18-60 years with allergic rhinitis diagnosed according to Chinese clinical guidelines were randomized 1:1 to an experimental group (AI-assisted ultrasound-guided needling) or a control group (conventional blind needling), 30 per group. All needling was performed by the same acupuncturist.
Intervention: Both groups received bilateral acupuncture at the Xinwu point (sphenopalatine ganglion) once every 7 days for 6 sessions. In the experimental group, a low-frequency ultrasound probe with an AI image-recognition program labeled anatomical landmarks (including the condylar process, coronoid process, neurovascular bundle, maxilla, and lateral pterygoid plate) in real time, and the needle was advanced in-plane to the pterygopalatine fossa. In the control group, the same needle type and success criteria were used without ultrasound or AI guidance.
Primary outcomes: needling success rate, first-pass success rate, and mean number of punctures.
Secondary outcomes: adverse-event rate, Total Nasal Symptom Score (TNSS), total effective rate based on TNSS improvement, and scores on a self-designed patient-acceptance scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label because AI ultrasound guidance and blind needling cannot be concealed from participants or the operator.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of allergic rhinitis according to the Chinese Guideline for the Diagnosis and Treatment of Allergic Rhinitis (2022, revised edition)
- •Age 18 to 60 years
- •No acupuncture or anti-allergic medication other than the study intervention within the preceding week
- •Written informed consent and ability to complete treatment and follow-up
排除标准
- •Serious underlying diseases of the heart, brain, liver, or kidney
- •Systemic corticosteroid use or allergen immunotherapy within the preceding 3 months
- •Other nasal disorders such as sinusitis, nasal polyps, or marked nasal septum deviation
- •Coagulation abnormalities or long-term use of anticoagulants (e.g., warfarin or aspirin)
- •Pregnancy, lactation, or planned pregnancy
- •Impaired consciousness or verbal expression precluding cooperation with assessment
研究组 & 干预措施
AI-guided needling
AI-assisted real-time ultrasound visualization-guided acupuncture at the Xinwu point (sphenopalatine ganglion).
干预措施: AI-guided Xinwu-point acupuncture (Procedure)
Conventional blind needling
Conventional blind acupuncture at the same Xinwu point without ultrasound or AI guidance.
干预措施: Blind Xinwu-point acupuncture (Procedure)
结局指标
主要结局
Needling success rate
时间窗: During 6 weekly treatment sessions, up to 6 weeks
Percentage of punctures that successfully hit the sphenopalatine ganglion (Xinwu point), defined by an electric-shock-like or water-spray nasal sensation with rapid improvement in nasal ventilation. Calculated as successful hits divided by total punctures over 6 sessions (bilateral).
First-pass success rate
时间窗: During 6 weekly treatment sessions, up to 6 weeks
Percentage of needling attempts that hit the target with a single puncture (no reinsertion).
Mean number of punctures
时间窗: During 6 weekly treatment sessions, up to 6 weeks
Mean number of needle insertions required to achieve a successful hit of the Xinwu point (sphenopalatine ganglion).
次要结局
- Adverse-event rate(From first treatment through 1 week after the last session, up to 7 weeks)
- Change in Total Nasal Symptom Score (TNSS)(Baseline and 1 week after the last session, up to 7 weeks)
- Total effective rate(1 week after the last session)
- Patient-acceptance scale score(Day 1, within 10 minutes after the first treatment)
研究者
Yi-Tan Che
Attending Physician
Daxing Teaching Hospital, Capital Medical University