Clinical Trial Study on the Improved New Method of Acupotomy for Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bath Ankylosing Spondylitis Disease Activity Index
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 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.
排除标准
- •Complicated with other autoimmune diseases except for the research disease.
- •Complete ankylosis or deformity of the spine.
- •Pregnant or lactating women.
- •Complicated with severe cardiovascular and cerebrovascular diseases, liver or kidney failure, malignant tumors, or coagulation disorders.
- •Patients whose data collection is affected by mental, language or other factors.
- •Patients with psoriatic arthritis, reactive arthritis, or inflammatory bowel disease-associated spondyloarthritis.
研究组 & 干预措施
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.
干预措施: Acupotomy (Procedure)
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.
干预措施: Sham Acupotomy (Procedure)
结局指标
主要结局
Bath Ankylosing Spondylitis Disease Activity Index
时间窗: Week 0, Week 2, Week 4, Week 8
Based on the patient's symptoms over the past week, an assessment is conducted through six questions. The first five questions are scored using a Visual Analog Scale (VAS, 0-10 points). The calculation formula is generally expressed as: BASDAl = 0.2x(A+B+C+D+(E+ F)/2) Where: A represents the degree of fatigue/tiredness; B represents the degree of pain in the neck, back, or hips; C represents the degree of pain/swelling in other joints; D represents the level of discomfort from bodily tenderness or pressure pain; E represents the severity of morning stiffness; F represents the duration of morning stiffness (converted to a 0-10 score). BASDAI 24 indicates high disease activity, while a score \<4 suggests lower disease activity.
次要结局
未报告次要终点
研究者
zhouzipeng
Chief physician
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine