About this trial
This study is a multicenter, prospective cohort study designed to systematically evaluate the clinical efficacy of integrated Traditional Chinese and Western Medicine on short-term functional improvement in patients with ankylosing spondylitis, with the Bath Ankylosing Spondylitis Functional Index (BASFI) at 6 months of treatment as the primary outcome measure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients with Ankylosing spondylitis
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a 10-item instrument used to measure functional limitation in patients with ankylosing spondylitis. Each item is scored on a 0 to 10 visual analog scale, where 0 indicates easy and 10 indicates impossible. The total score is calculated as the mean of the 10 item scores and ranges from 0 to 10. Higher scores indicate worse functional status.
Secondary outcomes
The Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a 10-item instrument used to measure functional limitation in patients with ankylosing spondylitis. Each item is scored on a 0 to 10 visual analog scale, where 0 indicates easy and 10 indicates impossible. The total score is calculated as the mean of the 10 item scores and ranges from 0 to 10. Higher scores indicate worse functional status.
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a 6-item instrument used to measure disease activity in participants with ankylosing spondylitis. It evaluates fatigue, spinal pain, peripheral joint pain and swelling, localized tenderness, and morning stiffness (severity and duration) over the past week. Each item is scored on a 0 to 10 scale, with higher scores indicating greater disease activity. The total BASDAI score is calculated as 0.2 × (Item 1 + Item 2 + Item 3 + Item 4 + (Item 5 + Item 6)/2) and ranges from 0 to 10. Higher scores indicate worse disease activity. A BASDAI score of 4 or higher is commonly considered to indicate high disease activity.
Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP)
The Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) is a composite index used to measure disease activity in participants with ankylosing spondylitis. It combines patient-reported items and C-reactive protein (CRP) levels into a single score. The minimum score is 0, with lower scores indicating lower disease activity and higher scores indicating worse disease activity. There is no fixed maximum value because the upper end of the scale depends on the CRP level. ASDAS-CRP disease activity states are defined as inactive disease (\<1.3), moderate disease activity (1.3 to \<2.1), high disease activity (2.1 to ≤3.5), and very high disease activity (\>3.5). Clinically important improvement is defined as a decrease of at least 1.1 units, and major improvement is defined as a decrease of at least 2.0 units.
The Bath Ankylosing Spondylitis Metrology Index (BASMI)
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an instrument used to measure axial skeletal mobility in participants with ankylosing spondylitis. The total score ranges from 0 to 10. Lower scores indicate better spinal and hip mobility, while higher scores indicate greater limitation of movement and worse axial mobility.
Sponsors and contacts
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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