Ankylosing Spondylitis Clinical Trials

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Clinical Trial Study on the Improved New Method of Acupotomy for Ankylosing Spondylitis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Meeting the revised New York Criteria (1984) or the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis (2009).

• Aged 18 to 75 years old.

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 points.

• Having signed the informed consent form.

Locations
Other Locations
China
The Second Affiliated Hospital of Henan University of Chinese Medicine
RECRUITING
Zhengzhou
Contact Information
Primary
zhouzipeng Chief physician
13613863247@163.com
13613863247
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 60
Treatments
Experimental: Treatment Group
All subjects were enrolled at week 0 and, after completing baseline assessments, received acupotomy treatment once per week for a total of four sessions over the initial three-week period. The core intervention for the treatment group (acupotomy group) involved ultrasound-guided precise release: first, the target vertebra with the most significant lesions was identified through palpation and ultrasound imaging, after which the acupotomy was accurately guided in real-time via ultrasound to the interspinous points (located at the interspinous ligaments) and paraspinal points (located at the intertransverse ligaments) of the target vertebra and adjacent vertebrae for release.
Sham_comparator: Control Group
The control group (sham acupotomy group) strictly replicated all preliminary procedures of the treatment group, including exploration, ultrasound localization, and local anesthesia. However, the acupotomy needle only pierced the epidermis without performing any release operations in the deeper tissues, thereby maintaining blinding and assessing the specific effect of the acupotomy therapy.
Related Therapeutic Areas
Sponsors
Leads: Henan Provincial People's Hospital
Collaborators: The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

This content was sourced from clinicaltrials.gov