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NCT Number: NCT03420404

Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

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.

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Key information

Conditions

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

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169608

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 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).

Treatment and study plan

TCM physician involved collaborative care model (TCMCMC)

Other

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.

Primary outcomes

  1. Mean difference in spinal pain score

    Time frame: Baseline, Week 6

    Mean difference in spinal pain score between intervention and control groups at week 6 of treatment.

Secondary outcomes

  1. Mean difference in spinal pain score

    Time frame: Baseline, Week 12, Week 24

    Mean difference in spinal pain score between intervention and control groups at week 12 and week 24 of treatment.

  2. Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Baseline, Week 6, Week 12, Week 24

    Mean difference in BASDAI score between intervention and control groups at week 6, week 12 and week 24 of treatment.

  3. Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Baseline, Week 6, Week 12, Week 24

    Mean difference in BASFI score between intervention and control groups at week 6, week 12 and week 24 of treatment.

  4. Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)

    Time frame: Baseline, Week 6, Week 12, Week 24

    Mean difference in BAS-G score between intervention and control groups at week 6, week 12 and week 24 of treatment.

  5. Mean difference in Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, Week 6, Week 12, Week 24

    Mean difference in HAQ score between intervention and control groups at week 6, week 12 and week 24 of treatment.

  6. Mean difference in 36-Item Short Form Survey (SF-36)

    Time frame: Baseline, Week 6, Week 12, Week 24

    Mean difference in SF-36 score between intervention and control groups at week 6, week 12 and week 24 of treatment.

  7. Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)

    Time frame: Baseline, Week 6, Week 12, Week 24

    Mean difference in AsQoL score between intervention and control groups at week 6, week 12 and week 24 of treatment.

  8. Mean difference in consultation fees (rheumatologist and other outpatient) and drugs

    Time frame: Week 6, Week 12, Week 24

    Mean difference in consultation fees and drugs between intervention and control groups at week 6, week 12 and week 24 of treatment.

  9. Mean difference in costs of laboratory procedures and imaging

    Time frame: Week 6, Week 12, Week 24

    Mean difference in costs of laboratory procedures and imaging between intervention and control groups at week 6, week 12 and week 24 of treatment.

  10. Mean difference in number of inpatient days

    Time frame: Week 6, Week 12, Week 24

    Mean difference in number of inpatient days between intervention and control groups at week 6, week 12, week 24 of treatment.

Other outcomes

  1. Mean difference in spinal pain score

    Time frame: Baseline, Week 52

    Mean difference in spinal pain score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  2. Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Baseline, Week 52

    Mean difference in BASDAI score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  3. Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Baseline, Week 52

    Mean difference in BASFI score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  4. Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)

    Time frame: Baseline, Week 52

    Mean difference in BAS-G score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  5. Mean difference in Health Assessment Questionnaire (HAQ)

    Time frame: Baseline, Week 52

    Mean difference in HAQ score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  6. Mean difference in 36-Item Short Form Survey (SF-36)

    Time frame: Baseline, Week 52

    Mean difference in SF-36 score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  7. Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)

    Time frame: Baseline, Week 52

    Mean difference in AsQoL score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  8. Mean difference in consultation fees (rheumatologist and other outpatient) and drugs

    Time frame: Week 52

    Mean difference in consultation fees and drugs between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  9. Mean difference in number of inpatient days

    Time frame: Week 52

    Mean difference in number of inpatient days between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  10. Mean difference in costs of laboratory procedures and imaging

    Time frame: Week 52

    Mean difference in costs of laboratory procedures and imaging between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Duke-NUS Graduate Medical School
  • National University of Singapore
  • Saw Swee Hock School of Public Health
  • Thong Chai Medical Institute Singapore

Registry information

Official study title

A Pragmatic Randomized Controlled Trial of a Novel TCM Physician-involved Collaborative Care Model in the Management of Patients With Axial Spondyloarthritis in Singapore (AcuSpA)

Acronym: AcuSpA

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Feb 5, 2018
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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