Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis (AS): A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System

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, 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.

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.

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.

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.

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.

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.

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.

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.

To monitor systemic inflammation and disease activity in patients with ankylosing spondylitis (AS).

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.

Treatment adherence is assessed based on the use of traditional Chinese medicine (TCM) and Western medicine during the two-year follow-up period.

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).

To assess the use of non-steroidal anti-inflammatory drugs (NSAIDs) by participants during the study period.