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).
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.
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
Patients with Ankylosing spondylitis
Cohort
Other
Not listed
The change in Spondyloarthritis Research Consortium of Canada (SPARCC) scores from baseline to 12 months
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.
The change in SPARCC scores from baseline to 24 months
The change in SPARCC scores from baseline to 24 months, which is added to evaluate the longer-term durability of the treatment effect and to capture potential continued improvement or late-onset changes in spinal inflammation beyond the first year.
The longitudinal progression of spinal inflammation
We will use the trajectory of SPARCC score changes at baseline, 12 months, and 24 months during the prospective follow-up to evaluate the longitudinal progression of spinal inflammatory lesions.
The Bath Ankylosing Spondylitis Functional Index (BASFI)
To define and monitor physical functioning in patients with ankylosing spondylitis (AS). Score range is 0 - 10, with 0 reflecting no functional impairments and 10 reflecting maximal impairment.
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
To measure patient-reported disease activity in patients with ankylosing spondylitis (AS). Score ranges from 0 (no disease activity) to 10 (maximal disease activity). A cut off of 4 is used to define active disease. High disease activity: BASDAI ≥ 4; low disease activity: \< 4.
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China-Japan Friendship Hospital
Lead sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
Guangxi Ruikang Hospital
Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborator
Beijing Electric Power Hospital
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Collaborator
Xi'an Fifth Hospital
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
Shanghai University of Traditional Chinese Medicine
Collaborator
Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
Collaborator
