Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07578220

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants receive weekly acupotomy or sham acupotomy treatments for four sessions over three weeks.

4 weekly visits (in-person)

Follow-up

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

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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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