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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorChina-Japan Friendship Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

790 Participants
are grouped into 2 trial groups
Group A: exposed group
Group B: non-exposed group

Trial outcomes

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.

Other outcomes

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