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Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

NCT03420404 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-11-25

No results posted yet for this study

Summary

A pragmatic, prospective, randomized controlled trial will be conducted in patients with axial spondyloarthritis who are NSAID inadequate responders. Patients will be randomized in a 1:1 ratio to either receive standard rheumatological care or a Traditional Chinese Medicine physician involved collaborative model of care (i.e. NSAIDs with acupuncture). Primary end-point was spinal pain score at week 6 with secondary end-points being evaluated week 24. Through this study, we hope to assess a novel model of care in AxSpA and be used as a reference to improve the management of other chronic diseases in Singapore.

Conditions

  • Axial Spondyloarthritis

Interventions

OTHER

TCM physician involved collaborative care model (TCMCMC)

TCM physician delivered acupuncture as well as history taking, physical examination, non-pharmacological advice and communications with rheumatologists. Acupuncture procedures: After eliciting the deqi sensation, the needles will be left in place for 30 minutes. The acupuncture treatment will be done 2-3 times a week, with 5 sessions constituting a treatment course. There will be a break of 1 week in between each acupuncture course. Patients in the intervention arm will undergo 2 treatment courses (or 10 sessions) in total.

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Saw Swee Hock School of Public Health

    collaborator UNKNOWN

  • National University of Singapore

    collaborator OTHER

  • Thong Chai Medical Institute Singapore

    collaborator UNKNOWN

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Warren Fong · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2024-12-30
Completion
2025-12-31

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03420404 on ClinicalTrials.gov