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).
Study Type
OBSERVATIONAL
Enrollment
210
China-Japan Friendship Hospital
Beijing, Beijing, China, China
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.
Time frame: Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead.
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.
Time frame: 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
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.
Time frame: Assessed annually in the two-year follow-up period ahead.
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.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
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.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
To measure disease activity in ankylosing spondylitis (AS) based on a composite score of domains relevant to patients and clinicians, including both self-reported items and objective measures. Score ranges from 0 (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. It defined 4 important disease states: inactive disease, moderate, high, and very high disease activity, and relevant cut offs between these states were 1.3, 2.1, and 3.5 units, respectively. Clinically important improvement was found to be 1.1 units or greater and major improvement was defined as a change of 2.0 units or more.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Bath Ankylosing Spondylitis Metrology Index (BASMI)
To quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement. Score ranges from 0 to 10. A lower score indicates better mobility of the spine and hips, and less severe structural damage. A higher score indicates more severe joint ankylosis and restricted movement, and that the disease has caused significant structural consequences.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Ankylosing Spondylitis Quality of Life Scale(ASQoL)
To measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective. Score range is 0-18. The score directly reflects the extent to which quality of life has been impaired; the lower the score, the better the quality of life has been maintained; conversely, the higher the score, the more severe the negative impact of the illness on quality of life.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The Visual Analogue Scale (VAS)
To reflect the level of pain. Pain intensity is rated on a scale of 0 to 10. 0: no pain/absolutely none; 10: the most severe pain/unbearable, extreme discomfort.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Inflammatory marker: the serum C-reactive protein (CRP) levels
To monitor systemic inflammation and disease activity in patients with ankylosing spondylitis (AS).
Time frame: 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)
AEs and SAEs including gastrointestinal reactions, abnormal liver and kidney function, and cardiovascular events. These conditions are monitored based on symptoms reported by patients, as well as routine blood and urine tests, faecal occult blood tests, liver and kidney function tests, and electrocardiograms.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Treatment adherence
Treatment adherence is assessed based on the use of traditional Chinese medicine (TCM) and Western medicine during the two-year follow-up period.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
Time to discontinuation of Western medication
The time period from the first dose of Western treatment to the permanent discontinuation of any Western medicine (including non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs)) for ankylosing spondylitis (AS).
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
The use of non-steroidal anti-inflammatory drugs (NSAIDs)
To assess the use of non-steroidal anti-inflammatory drugs (NSAIDs) by participants during the study period.
Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
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