A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

China-Japan Friendship Hospital60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

Ultrasound-guided acupotomy

Ultrasound-guided acupotomy will be performed once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The target vertebral level and treatment sites will be identified by physical examination and ultrasound imaging. Following routine skin preparation and local anesthesia, the acupotomy needle will be advanced under real-time ultrasound guidance to the predefined interspinous and paraspinal treatment sites, where tissue release will be performed according to the standardized treatment protocol.

Sham AcupotomyPROCEDURE

Sham acupotomy will be performed once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The same preliminary procedures as those used in the experimental group will be followed, including physical examination, ultrasound localization, skin preparation, and local anesthesia. The acupotomy needle will only penetrate superficially, without advancement to the target deep tissues or performance of tissue release.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. Aged 18-75 years. 3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAl) score ≥4. 4. Provision of written informed consent. Exclusion Criteria: 1. Presence of other autoimmune or inflammatory rheumatic diseases that may affect outcome assessment, including psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis; 2. Complete spinal ankylosis, severe spinal deformity, previous spinal surgery, or spinal trauma affecting the target treatment area; 3. Severe cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, malignancy, coagulation disorders, or other conditions considered unsuitable for the intervention; 4. Pregnancy or breastfeeding; 5. Cognitive impairment or communication difficulties that may affect outcome assessment; 6. Use of biologic agents, targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), systemic corticosteroids, or other immunomodulatory therapies within the previous month; 7. Previous acupotomy treatment at the target anatomical site within the previous 3 months; 8. Known metal allergy or severe fear of acupotomy procedures.

Outcomes

Primary Outcomes

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score

The primary outcome is the between-group difference in change from baseline in BASDAI score at week 4 after intervention.

Time frame: Week 4,one week after the final treatment session

Secondary Outcomes

Longitudinal changes in BASDAI scores at weeks 2, 4, and 8

The change from baseline in BASDAI will be assessed to evaluate disease activity after intervention.