AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis

NCT07778537 | Completed

• 1 other identifier: 20250812KY-YJ-30
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Rhinitis, Allergic

Keywords

acupuncture; sphenopalatine ganglion; Xinwu point; ultrasound guidance; artificial intelligence; needling accuracy

Outcome Measures

Primary Outcomes (3)

• 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).

  During 6 weekly treatment sessions, up to 6 weeks

• First-pass success rate

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

  During 6 weekly treatment sessions, up to 6 weeks

• Mean number of punctures

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

  During 6 weekly treatment sessions, up to 6 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

AI-guided needling

EXPERIMENTAL

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

Procedure: AI-guided Xinwu-point acupuncture

Conventional blind needling

ACTIVE COMPARATOR

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

Procedure: Blind Xinwu-point acupuncture

Interventions

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.

AI-guided needling

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.

Conventional blind needling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daxing Teaching Hospital, Capital Medical University: lead

Study Sites (1)

Daxing Teaching Hospital of Capital Medical University

Beijing, Beijing Municipality, 102600, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label because AI ultrasound guidance and blind needling cannot be concealed from participants or the operator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Two parallel groups: AI-guided needling versus conventional blind needling of the same acupoint.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 21, 2026
• Study Start: September 20, 2025
• Primary Completion: June 8, 2026
• Study Completion: June 8, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication, for 3 years
• Access Criteria: Qualified researchers with a methodologically sound proposal, after ethics approval and a signed data-use agreement.

Locations

CN (1)