Allergic Rhinitis, Rhinitis, Allergic
Conditions
Keywords
acupuncture, sphenopalatine ganglion, Xinwu point, ultrasound guidance, artificial intelligence, needling accuracy
Brief summary
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.
Detailed description
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. This registration is retrospective because enrollment and follow-up were completed before the record was submitted.
Interventions
Bilateral acupuncture at the Xinwu point (sphenopalatine ganglion) once every 7 days for 6 sessions, guided by ultrasound with an AI anatomical-recognition program. Disposable filiform needle 0.35 mm x 60 mm.
Bilateral acupuncture at the Xinwu point once every 7 days for 6 sessions using conventional surface-landmark blind needling. Same needle type and treatment schedule as the experimental arm.
Sponsors
Study design
Masking description
Open-label because AI ultrasound guidance and blind needling cannot be concealed from participants or the operator.
Intervention model description
Two parallel groups: AI-guided needling versus conventional blind needling of the same acupoint.
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needling success rate | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse-event rate | From first treatment through 1 week after the last session, up to 7 weeks | Number of adverse events divided by total needling laterality-sessions (360 per group). |
| Change in Total Nasal Symptom Score (TNSS) | Baseline and 1 week after the last session, up to 7 weeks | TNSS (0-16) for nasal congestion, itching, sneezing, and rhinorrhea. |
| Total effective rate | 1 week after the last session | Proportion of participants with TNSS improvement rate ≥26%. |
| Patient-acceptance scale score | Day 1, within 10 minutes after the first treatment | Total score (10-50) on a self-designed 10-item Likert acceptance scale. |
Countries
China