RecruitingNot ApplicableNCT07578220

A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

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

Sponsor

China-Japan Friendship Hospital

Enrollment

60 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Ankylosing Spondylitis

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Acupotomy and a procedure called Sham Acupotomy for people with ankylosing spondylitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUltrasound-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.

PROCEDURESham 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.