Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis: A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Spondyloarthritis Research Consortium of Canada (SPARCC) score
研究概览
简要总结
This study is a multicentre, ambidirectional, observational cohort study. The ambidirectional design incorporates both the collection of retrospective data from the three years prior to enrolment, and a prospective follow-up period of up to two years. The study is designed to evaluate the long-term effects of Integrated Medicine on radiographic progression in patients diagnosed with Ankylosing spondylitis (AS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •fulfill the 1984 modified New York criteria for ankylosing spondylitis or the 2009 Assessment of SpondyloArthritis International Society (ASAS) classification criteria for axial spondyloarthritis
- •age between 18 and 75 years
- •sign informed consent.
排除标准
- •diagnosis of other autoimmune diseases besides the disease under investigation (e.g., rheumatoid arthritis, Sjögren's syndrome, erythema nodosum, myositis, etc.)
- •pregnancy or lactation
- •comorbid severe cardiovascular or cerebrovascular diseases, hepatic or renal failure, or malignancy
- •spondyloarthritis related to enteropathic arthritis, psoriatic arthritis, or reactive arthritis
- •unable to provide data due to mental, language, or similar factors.
研究组 & 干预措施
exposed group
Participants who receive traditional Chinese medicine (TCM) therapy for more than 60% of the total duration of their prospective follow-up period.
non-exposed group
Participants who do not receive any TCM therapy.
结局指标
主要结局
Spondyloarthritis Research Consortium of Canada (SPARCC) score
时间窗: Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead.
Assess the extent of inflammation throughout the spine (cervical, thoracic and lumbar regions). Select six consecutive vertebral units showing the most pronounced oedema (each unit comprising the vertebral body and the two inferior vertebral angles) for scoring; the total score ranges from 0 to 30 points. A reduction in the total score before and after treatment (e.g. from 20 to 8 points) indicates that the inflammation has been effectively controlled.
The change in Spondyloarthritis Research Consortium of Canada (SPARCC) scores from baseline to 12 months
时间窗: Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead.
The primary outcome measure assesses the changes in spinal inflammation following one year of Integrated Traditional Chinese and Western Medicine (Integrated Medicine) treatment. Select six consecutive vertebral units showing the most pronounced oedema (each unit comprising the vertebral body and the two inferior vertebral angles) for scoring; the total score ranges from 0 to 30 points. A reduction in the total score before and after treatment (e.g. from 20 to 8 points) indicates that the inflammation has been effectively controlled.
次要结局
- The Bath Ankylosing Spondylitis Functional Index (BASFI)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The Bath Ankylosing Spondylitis Metrology Index (BASMI)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The Ankylosing Spondylitis Quality of Life Scale(ASQoL)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The Visual Analogue Scale (VAS)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- Inflammatory marker: the serum C-reactive protein (CRP) levels(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- Treatment adherence(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- Time to discontinuation of Western medication(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The use of non-steroidal anti-inflammatory drugs (NSAIDs)(At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.)
- The change in SPARCC scores from baseline to 24 months(Review the imaging data from up to three years prior to enrolment and assessed at baseline and 24 months.)
- The longitudinal progression of spinal inflammation(Assessed annually in the two-year follow-up period ahead.)
研究者
Qingwen Tao
Chief physician
China-Japan Friendship Hospital