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AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis

A Study of Artificial Intelligence-Assisted Visualization-Guided Acupuncture at the "Xinwu Point" for Allergic Rhinitis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07778537
Enrollment
60
Registered
2026-08-21
Start date
2025-09-20
Completion date
2026-06-08
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Rhinitis, Allergic

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

PROCEDUREAI-guided Xinwu-point acupuncture

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.

PROCEDUREBlind Xinwu-point acupuncture

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

Daxing Teaching Hospital, Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Needling success rateDuring 6 weekly treatment sessions, up to 6 weeksPercentage 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 rateDuring 6 weekly treatment sessions, up to 6 weeksPercentage of needling attempts that hit the target with a single puncture (no reinsertion).
Mean number of puncturesDuring 6 weekly treatment sessions, up to 6 weeksMean number of needle insertions required to achieve a successful hit of the Xinwu point (sphenopalatine ganglion).

Secondary

MeasureTime frameDescription
Adverse-event rateFrom first treatment through 1 week after the last session, up to 7 weeksNumber 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 weeksTNSS (0-16) for nasal congestion, itching, sneezing, and rhinorrhea.
Total effective rate1 week after the last sessionProportion of participants with TNSS improvement rate ≥26%.
Patient-acceptance scale scoreDay 1, within 10 minutes after the first treatmentTotal score (10-50) on a self-designed 10-item Likert acceptance scale.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026