A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis
NCT07578220
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
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.
Conditions2
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NCT07578220