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RECRUITING
NCT07578220
NA

A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

Sponsor: China-Japan Friendship Hospital

View on ClinicalTrials.gov

Summary

This study employs a randomized controlled trial methodology to systematically evaluate the efficacy and safety of a modified acupotomy technique in the treatment of ankylosing spondylitis. Through ultrasound-guided localization, the operative sites are assessed to clarify the improvement effect of the modified acupotomy on disease activity in AS patients. The aim is to enhance the clinical outcomes of AS, provide evidence-based medical support for acupotomy treatment of AS, and improve the diagnosis and treatment standards for the condition.

Official title: Ultrasound-Guided Acupotomy for Ankylosing Spondylitis: A Protocol for a Participant- and Assessor-Blinded, Sham-Controlled Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-02

Completion Date

2028-06-30

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

PROCEDURE

Ultrasound-guided acupotomy

Ultrasound-guided acupotomy will be performed once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The target vertebral level and treatment sites will be identified by physical examination and ultrasound imaging. Following routine skin preparation and local anesthesia, the acupotomy needle will be advanced under real-time ultrasound guidance to the predefined interspinous and paraspinal treatment sites, where tissue release will be performed according to the standardized treatment protocol.

PROCEDURE

Sham Acupotomy

Sham acupotomy will be performed once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The same preliminary procedures as those used in the experimental group will be followed, including physical examination, ultrasound localization, skin preparation, and local anesthesia. The acupotomy needle will only penetrate superficially, without advancement to the target deep tissues or performance of tissue release.

Locations (1)

The Second Affiliated Hospital of Henan University of Chinese Medicine

Henan, Zhengzhou, China