New modified acupotomy method for ankylosing spondylitis
Clinical Trial Study on the Improved New Method of Acupotomy for Ankylosing Spondylitis
This study tests whether a modified ultrasound-guided acupotomy can reduce disease activity and symptoms in adults (18–75) with active ankylosing spondylitis (BASDAI ≥4) compared with a sham procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Henan, Zhengzhou) |
| Trial ID | NCT07578220 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–75 who meet the 1984 New York or 2009 ASAS criteria for axial spondyloarthritis, have BASDAI ≥4, and can provide informed consent are ideal candidates.
Not a fit: Patients with complete spinal ankylosis or deformity, other autoimmune spondyloarthropathies (psoriatic/reactive/IBD-associated), severe comorbidities, coagulation disorders, or who are pregnant or lactating are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the procedure could lower disease activity and pain and offer a minimally invasive treatment option to improve function and quality of life for people with AS.
How similar studies have performed: Small studies of acupotomy and related minimally invasive needle-knife techniques have shown benefits for some musculoskeletal pains, but randomized data specifically in ankylosing spondylitis are limited and the ultrasound-guided modification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. Age 18-75 years 3. BASDAI ≥4 4. Signed informed consent form Exclusion Criteria: 1. Presence of autoimmune diseases other than the studied condition 2. Complete spinal ankylosis or spinal deformity 3. Pregnant or lactating women 4. Comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, malignant tumors, or coagulation disorders 5. Patients unable to comply with data collection due to mental, linguistic, or similar factors 6. Patients with psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis
Where this trial is running
Henan, Zhengzhou
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.