Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

  • STATUS
    Recruiting
  • End date
    Oct 26, 2022
  • participants needed
    160
  • sponsor
    Singapore General Hospital
Updated on 26 January 2021
steroidal anti-inflammatory drugs
traditional chinese medicine
prednisolone
NSAID
biological therapy
spinal pain
DMARD
anti-rheumatic drugs
cox-2 inhibitor

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.

Description

The objective of this study is to determine the clinical effectiveness, safety and cost-effectiveness of a new model of care in the management of Spondyloarthritis (AxSpA) using a pragmatic trial approach. In this study, we define TCM physician involved collaborative model of care (TCMCMC) as TCM physician delivered acupuncture as well as TCM physician's history taking, physical examination, non-pharmacological advice and communications with rheumatologists in addition to the usual rheumatological care. The TCMCMC involves TCM physicians diagnosing patients based on TCM clinical syndromes and prescribing standardised acupuncture treatment. The patient population will still receive their standard of care (drug therapy and physiotherapy) as background therapy. The proposed study will not be investigating any therapeutic or medicinal products (drugs).

Our primary hypothesis is that novel TCMCMC in patients with AxSpA will result in better pain control as compared the usual rheumatological care. Secondary hypothesis is that TCMCMC will have greater improvements in other clinical, quality of life, and economic outcomes as compared with those under the usual rheumatological care.

Details
Condition Axial Spondyloarthritis
Treatment TCM physician involved collaborative care model (TCMCMC)
Clinical Study IdentifierNCT03420404
SponsorSingapore General Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age or older
Have AxSpA, diagnosed according to the 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
Have active disease based on Bath AS Disease Activity Index (BASDAI) score 4 on a 11-point Numerical Rating Scale (NRS) and spinal pain score 4 on a 11-point NRS
Has failed 2 sequential NSAIDs (including COX-2 inhibitor) at maximal tolerated doses for 4 weeks
No biologic therapy (i.e tumour necrosis factor blocker or anti-interleukin 17) within the past three months
Patient who is on current treatment with concomitant methotrexate (MTX) or sulfasalazine (SSZ) at study entry must be on the drug for 12 weeks and at stable dose for 4 weeks prior to randomisation. Patients who are on non-biologic disease-modifying antirheumatic drugs (DMARDs) other than methotrexate or sulfasalazine must discontinue the DMARD 4 weeks prior to randomisation, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed. Patients taking systemic corticosteroids have to be on stable dose of 10mg/day prednisolone or equivalent for at least two weeks before randomisation

Exclusion Criteria

Pregnant or breastfeeding women
On anti-platelet agents (i.e. aspirin, clopidogrel, dipyridamole, etc) and anti-coagulants (i.e. warfarin, enoxaparin, rivaroxaban, dabigatran, etc)
Have bleeding disorders
Have blood-borne communicable diseases (e.g. hepatitis B, hepatitis C, human immunodeficiency virus, etc)
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