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CompletedNCT07778537Updated Aug 21, 2026

AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis

An interventional study of AI-guided Xinwu-point acupuncture and Blind Xinwu-point acupuncture in Allergic Rhinitis and Rhinitis, Allergic, sponsored by Daxing Teaching Hospital, Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Daxing Teaching Hospital, Capital Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Allergic Rhinitis
  • Rhinitis, Allergic

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Keywords

  • acupuncture
  • sphenopalatine ganglion
  • Xinwu point
  • ultrasound guidance
  • artificial intelligence
  • needling accuracy
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    AI-guided needling

    AI-assisted real-time ultrasound visualization-guided acupuncture at the Xinwu point (sphenopalatine ganglion).

    Procedure: AI-guided Xinwu-point acupuncture

  • Active comparator
    Conventional blind needling

    Conventional blind acupuncture at the same Xinwu point without ultrasound or AI guidance.

    Procedure: Blind Xinwu-point acupuncture

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.

05

What researchers measure

Primary outcomes

  1. Needling success rate

    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).

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

  2. First-pass success rate

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

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

  3. Mean number of punctures

    Mean number of needle insertions required to achieve a successful hit of the Xinwu point (sphenopalatine ganglion).

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

Secondary outcomes

  1. Adverse-event rate

    Number of adverse events divided by total needling laterality-sessions (360 per group).

    Time frame: From first treatment through 1 week after the last session, up to 7 weeks

  2. Change in Total Nasal Symptom Score (TNSS)

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

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

  3. Total effective rate

    Proportion of participants with TNSS improvement rate ≥26%.

    Time frame: 1 week after the last session

  4. Patient-acceptance scale score

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

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

06

Study locations

1 site
  • Daxing Teaching Hospital of Capital Medical University
    Beijing, Beijing Municipality 102600, China
07

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results of this study will be available from the corresponding author upon reasonable request after publication, subject to ethics committee approval and a data-use agreement. Data will not be posted in a public repository.

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07778537
Lead sponsor
Daxing Teaching Hospital, Capital Medical University
Responsible party
Yi-Tan Che (Attending Physician, Daxing Teaching Hospital, Capital Medical University) — Principal investigator
First posted
Aug 21, 2026
Start date
Sep 20, 2025
Primary completion
Jun 8, 2026
Completion
Jun 8, 2026
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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