Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Cohort Study

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• Spondylitis, Ankylosing 498

Spondylitis, Ankylosing

498 studies on the registry are indexed under Spondylitis, Ankylosing; 89 are open to participants now.

This study's planned enrollment of 790 is above the median of 200 across 210 observational studies indexed under Spondylitis, Ankylosing.

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 173 studies on the registry; 109 are open to participants now.

Study population

Groups and cohorts

• exposed group

  Participants who receive integrated Traditional Chinese and Western Medicine therapy during the follow-up period.

• non-exposed group

  Participants who receive only Western medicine therapy during the follow-up period.

Primary outcomes

1. 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.

   Time frame: At baseline, 6 months.

Secondary outcomes

1. 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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

2. 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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

3. 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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

4. 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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

5. The Ankylosing Spondylitis Quality of Life Scale(ASQoL)

   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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

6. Pain Score on the Visual Analogue Scale (VAS)

   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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

7. Serum C-reactive protein (CRP) Level

   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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

8. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

   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.

   Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

9. Adherence to Prescribed Traditional Chinese Medicine and Western Medicine

   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 frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

10. Time to Discontinuation of Western Medication

    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).

    Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

11. Use of Non-steroidal Anti-inflammatory Drugs (NSAIDs)

    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.

    Time frame: At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.

Individual participant data

Plan to share: No