RECRUITING Not applicable ClinicalTrials.gov

A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

Sponsor: China-Japan Friendship Hospital • ClinicalTrials.gov ID: NCT07578220

Registry updated: 2026-10-15

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Ultrasound-guided acupotomy (Procedure)
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.
Sham Acupotomy (Procedure)
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.

Eligibility criteria

Inclusion Criteria: 1. Meeting the 1984 revised New York criteria or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis. 2. Aged 18-75 years. 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAl) score ≥4. 4. Provision of written informed consent. Exclusion Criteria: 1. Presence of other autoimmune or inflammatory rheumatic diseases that may affect outcome assessment, including psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis; 2. Complete spinal ankylosis, severe spinal deformity, previous spinal surgery, or spinal trauma affecting the target treatment area; 3. Severe cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, malignancy, coagulation disorders, or other conditions considered unsuitable for the intervention; 4. Pregnancy or breastfeeding; 5. Cognitive impairment or communication difficulties that may affect outcome assessment; 6. Use of biologic agents, targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), systemic corticosteroids, or other immunomodulatory therapies within the previous month; 7. Previous acupotomy treatment at the target anatomical site within the previous 3 months; 8. Known metal allergy or severe fear of acupotomy procedures.

Conditions

Ankylosing Spondylitis

Locations

The Second Affiliated Hospital of Henan University of Chinese Medicine — Henan, Zhengzhou, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment