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

NCT07509775 | Recruiting

• 1 other identifier: 2025-KY-458
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• The change in SPARCC scores from baseline to 24 months

  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

  Assessed annually in the two-year follow-up period ahead.

• The Bath Ankylosing Spondylitis Functional Index (BASFI)

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

• The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),

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

• The Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Ankylosing spondylitis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• 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
• Shanghai University of Traditional Chinese Medicine: collaborator
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator
• Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital: collaborator
• Henan Province Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Chinese Medicine): collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing, China, 100029, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Yuanyuan Zou, Doctor

CONTACT

+86 18080935783; zyysdmn1234@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 3, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)