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

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

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 Overview

• Status: Recruiting
• Conditions: Ankylosing Spondylitis (AS)

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Yuanyuan Zou, Doctor; Phone Number: +86 18080935783; Email: zyysdmn1234@163.com

Study Locations

• China
  • Beijing, China
    • Beijing, Beijing, China, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Yuqiao Zhang, Doctor; Phone Number: +86 13520678396; Email: 13661102043@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Ankylosing spondylitis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
exposed group; Participants who receive traditional Chinese medicine (TCM) therapy for more than 60% of the total duration of their prospective follow-up period.
non-exposed group; Participants who do not receive any TCM therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Review the imaging data from up to three years prior to enrolment and assessed annually in the two-year follow-up period ahead.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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).	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.	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.	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).	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.	At baseline, 6 months, 12 months, 18 months, and 24 months post-enrollment.
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.	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.	Assessed annually in the two-year follow-up period ahead.

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Shanghai University of Traditional Chinese Medicine; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Beijing Electric Power Hospital; Hunan University of Traditional Chinese Medicine; Guangxi Ruikang Hospital; Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital; Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Affiliated Hospital of Shandong University of Traditional Chinese Medicine; Henan Province Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine); Xi'an Fifth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: 2025-KY-458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No