Actively Recruiting
Clinical Trial Study on the Improved New Method of Acupotomy for Ankylosing Spondylitis
Led by China-Japan Friendship Hospital · Updated on 2026-05-13
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
China-Japan Friendship Hospital
Lead Sponsor
T
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a modified acupotomy technique guided by ultrasound to treat ankylosing spondylitis (AS). This randomized controlled trial aims to assess the safety and effectiveness of this new method in reducing disease activity and improving clinical outcomes for people with AS. The study also seeks to provide evidence-based support to improve diagnosis and treatment standards for this condition. Participants will be randomly assigned to one of two groups. One group receives ultrasound-guided acupotomy targeting specific vertebral ligaments once a week for four sessions over three weeks. The other group receives a sham procedure mimicking the treatment process without actual tissue release to maintain blinding. Both groups undergo baseline assessments before treatment begins. Throughout the study, participants will complete assessments including the Bath Ankylosing Spondylitis Disease Activity Index at the start and after four weeks. Additional measures such as functional ability, disease activity scores, quality of life, pain levels, and medication use will be monitored at several points up to eight weeks. These evaluations help researchers understand treatment effects while ensuring participant safety during and after the intervention period.
CONDITIONS
Brief Title
Clinical Trial Study on the Improved New Method of Acupotomy for AS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the 1984 revised New York criteria or the 2009 ASAS classification criteria for axial spondyloarthritis
- Aged between 18 and 75 years
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher
- Signed informed consent form
You will not qualify if you...
- Have autoimmune diseases other than ankylosing spondylitis
- Complete spinal ankylosis or spinal deformity
- Are pregnant or breastfeeding
- Have severe cardiovascular or cerebrovascular diseases, liver or kidney failure, cancer, or blood clotting disorders
- Unable to comply with data collection due to mental, language, or similar issues
- Have psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive weekly acupotomy or sham acupotomy treatments for four sessions over three weeks.
4 weekly visits (in-person)
Duration - Up to 8 weeks from baseline
Participants are monitored for outcomes including disease activity and quality of life for up to 8 weeks after starting treatment.
Visits at Week 2, Week 4, and Week 8 (in-person)
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Henan University of Chinese Medicine
Henan, Zhengzhou, China, 450002
Actively Recruiting
Research Team
Y
Yuqiao Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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