Ankylosing Spondylitis (AS)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
China-Japan Friendship Hospital
Henan Province Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine)
Guangxi Ruikang Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Beijing Electric Power Hospital
Hunan University of Traditional Chinese Medicine
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Xi'an Fifth Hospital
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Bath Ankylosing Spondylitis Functional Index (BASFI) | At baseline, 6 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| The Bath Ankylosing Spondylitis Functional Index (BASFI) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | 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) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | 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) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | 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) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | 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. |
| The Ankylosing Spondylitis Quality of Life Scale(ASQoL) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | The Ankylosing Spondylitis Quality of Life Scale (ASQoL) is a patient-reported instrument used to measure the impact of ankylosing spondylitis on health-related quality of life. The total score ranges from 0 to 18. Lower scores indicate better quality of life, while higher scores indicate worse quality of life. |
| Pain Score on the Visual Analogue Scale (VAS) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | Pain due to ankylosing spondylitis measured on a 0 to 10 Visual Analogue Scale (VAS) over the past week, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. |
| Serum C-reactive protein (CRP) Level | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | Serum C-reactive protein (CRP) level measured in blood as a laboratory marker of systemic inflammation in participants with ankylosing spondylitis. Higher CRP levels indicate greater systemic inflammation. |
| 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. | Number of participants who experience adverse events (AEs) or serious adverse events (SAEs), including gastrointestinal reactions, abnormal liver function, abnormal kidney function, and cardiovascular events, as identified from participant-reported symptoms, routine blood and urine tests, fecal occult blood tests, liver and kidney function tests, and electrocardiograms. |
| Adherence to Prescribed Traditional Chinese Medicine and Western Medicine | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | Adherence to prescribed traditional Chinese medicine and Western medicine during the 2-year follow-up period, based on participant-reported and recorded medication use. |
| Time to Discontinuation of Western Medication | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | Time from the first dose of Western medication to the permanent discontinuation of any Western medication used for ankylosing spondylitis, including non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs). |
| Use of Non-steroidal Anti-inflammatory Drugs (NSAIDs) | At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment. | Use of non-steroidal anti-inflammatory drugs (NSAIDs) during the study period and changes over time, including NSAID type, dose, frequency, and duration, based on participant-reported and recorded medication use. |
Countries
China
Contacts
CONTACTJiaqi Liu
Outcome results
None listed