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Recruiting NCT07578220

Clinical Trial Study on the Improved New Method of Acupotomy for AS

No phase Interventional Ankylosing Spondylitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acupotomy, Sham Acupotomy.
Who it may be relevant to
Registry conditions: Ankylosing Spondylitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Acupotomy
    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 in
  • Procedure Sham Acupotomy
    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.

Primary outcome measures

  • Bath Ankylosing Spondylitis Disease Activity Index [Time frame: Week 0，Week 4]
Secondary outcome measures (7)
  • The Bath Ankylosing Spondylitis Disease Activity Index [Time frame: Week 0，Week 2，Week 8]
  • The Bath Ankylosing Spondylitis Functional Index [Time frame: Week 0，Week 2，Week 4，Week 8]
  • Ankylosing Spondylitis Disease Activity Score based on C-reactive protein [Time frame: Week 0，Week 2，Week 4，Week 8]
  • The Bath Ankylosing Spondylitis Metrology Index [Time frame: Week 0，Week 2，Week 4，Week 8]
  • The Ankylosing Spondylitis Quality of Life Scale [Time frame: Week 0，Week 2，Week 4，Week 8]
  • Pain Score on the Visual Analogue Scale [Time frame: Week 0，Week 2，Week 4，Week 8]
  • Use of Rescue Medication [Time frame: Week 0，Week 2，Week 4，Week 8]

Eligibility criteria

Inclusion criteria

  • Meeting the 1984 revised New York criteria or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis
  • Age 18-75 years
  • BASDAI ≥4
  • Signed informed consent form

Exclusion criteria

  • Presence of autoimmune diseases other than the studied condition
  • Complete spinal ankylosis or spinal deformity
  • Pregnant or lactating women
  • Comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, malignant tumors, or coagulation disorders
  • Patients unable to comply with data collection due to mental, linguistic, or similar factors
  • Patients with psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Henan University of Chinese Medicine — Henan

Identifiers

NCT: NCT07578220 · 2025-KY-458-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗