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NCT Number: NCT07778537

AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daxing Teaching Hospital of Capital Medical University

Beijing, Beijing Municipality, 102600, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-guided Xinwu-point acupuncture

Procedure

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.

Blind Xinwu-point acupuncture

Procedure

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.

Primary outcomes

  1. Needling success rate

    Time frame: 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).

  2. First-pass success rate

    Time frame: During 6 weekly treatment sessions, up to 6 weeks

    Percentage of needling attempts that hit the target with a single puncture (no reinsertion).

  3. Mean number of punctures

    Time frame: 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 outcomes

  1. Adverse-event rate

    Time frame: 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).

  2. Change in Total Nasal Symptom Score (TNSS)

    Time frame: Baseline and 1 week after the last session, up to 7 weeks

    TNSS (0-16) for nasal congestion, itching, sneezing, and rhinorrhea.

  3. Total effective rate

    Time frame: 1 week after the last session

    Proportion of participants with TNSS improvement rate ≥26%.

  4. Patient-acceptance scale score

    Time frame: Day 1, within 10 minutes after the first treatment

    Total score (10-50) on a self-designed 10-item Likert acceptance scale.

Sponsors and collaborators

Lead sponsor

Daxing Teaching Hospital, Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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