Ultrasound-Guided Acupotomy for Ankylosing Spondylitis: A Protocol for a Participant- and Assessor-Blinded, Sham-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting the 1984 revised New York criteria or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis.
- •Aged 18-75 years.
- •Bath Ankylosing Spondylitis Disease Activity Index (BASDAl) score ≥
- •Provision of written informed consent.
排除标准
- •Presence of other autoimmune or inflammatory rheumatic diseases that may affect outcome assessment, including psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis;
- •Complete spinal ankylosis, severe spinal deformity, previous spinal surgery, or spinal trauma affecting the target treatment area;
- •Severe cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, malignancy, coagulation disorders, or other conditions considered unsuitable for the intervention;
- •Pregnancy or breastfeeding;
- •Cognitive impairment or communication difficulties that may affect outcome assessment;
- •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;
- •Previous acupotomy treatment at the target anatomical site within the previous 3 months;
- •Known metal allergy or severe fear of acupotomy procedures.
研究组 & 干预措施
Ultrasound-guided acupotomy group
Participants assigned to the experimental group will receive ultrasound-guided acupotomy once weekly for four consecutive weeks (W0-W3), for a total of four treatment sessions. Before each treatment, 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.
干预措施: Ultrasound-guided acupotomy (Procedure)
Sham acupotomy group
Participants assigned to the sham comparator group will receive a sham acupotomy procedure once weekly for four consecutive weeks (W0-W3), for a total of four sessions. The sham procedure will replicate the preliminary procedures used in the experimental group, including physical examination, ultrasound localization, skin preparation, and local anesthesia. However, the acupotomy needle will only penetrate superficially and no deep tissue release will be performed.
干预措施: Sham Acupotomy (Procedure)
结局指标
主要结局
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
时间窗: Week 4,one week after the final treatment session
The primary outcome is the between-group difference in change from baseline in BASDAI score at week 4 after intervention.
次要结局
- Longitudinal changes in BASDAI scores at weeks 2, 4, and 8(Week 2，Week 4，Week 8)
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(Week 2，Week 4，Week 8)
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Week 2，Week 4，Week 8)
- Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)(Week 2，Week 4，Week 8)
- Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) score(Week 2，Week 4，Week 8)
- Change from baseline in Visual Analog Scale (VAS) pain score(Week 2，Week 4，Week 8)
- Incidence of adverse events(Baseline to Week 8)
研究者
Qingwen Tao
Chief physician
China-Japan Friendship Hospital