New modified acupotomy method for ankylosing spondylitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled study comparing a modified, ultrasound-guided acupotomy procedure to a sham acupotomy in patients with active ankylosing spondylitis. Ultrasound is used to localize operative sites before performing the minimally invasive needle-knife intervention or the sham procedure. Outcomes focus on changes in disease activity, symptom relief, and safety measures following the intervention. The trial aims to provide evidence to guide clinical use and standardize acupotomy techniques for AS.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Yuqiao Zhang
• Email: 2378731115@qq.com
• Phone: +86 13661102043

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.