AzTrials
AzTrials

Axial SpondyloarthritisAcuSpANCT03420404

Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

A study testing TCM physician involved collaborative care model (TCMCMC) in people with Axial Spondyloarthritis, run by Singapore General Hospital at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 21 to 100 years
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
TCM physician involved collaborative care model (TCMCMC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteSingapore
Study dates
5 Mar 2018to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore General Hospital

    Singapore, Singapore, 169608

Other trials in Singapore

About this study

Official 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)

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.

Read the detailed 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.

Being tested
TCM physician involved collaborative care model (TCMCMC)
Medical subject headings
Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03420404
Study groupRoleWhat they receive
Collaborative care with TCM physiciansExperimentalTCM physician involved collaborative care model (TCMCMC): The intervention arm will involve the TCM physician in the management of patients with AxSpA in addition to the usual rheumatological care.
Receives: Other: TCM physician involved collaborative care model (TCMCMC)
Usual care onlyNo interventionThe attending rheumatologist will prescribe a variety of treatment inclusive of medications such as non-steroidal anti-inflammatory drugs and physiotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean difference in spinal pain score

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

    Measured: Baseline, Week 6

Secondary outcomes (10)

  1. Mean difference in spinal pain score

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

    Measured: Baseline, Week 12, Week 24

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

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

    Measured: Baseline, Week 6, Week 12, Week 24

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

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

    Measured: Baseline, Week 6, Week 12, Week 24

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

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

    Measured: Baseline, Week 6, Week 12, Week 24

  5. Mean difference in Health Assessment Questionnaire (HAQ)

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

    Measured: Baseline, Week 6, Week 12, Week 24

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

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

    Measured: Baseline, Week 6, Week 12, Week 24

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

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

    Measured: Baseline, Week 6, Week 12, Week 24

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

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

    Measured: Week 6, Week 12, Week 24

  9. Mean difference in costs of laboratory procedures and imaging

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

    Measured: Week 6, Week 12, Week 24

  10. Mean difference in number of inpatient days

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

    Measured: Week 6, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start5 Mar 2018
  3. Primary completion30 Dec 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03420404
Sponsor's protocol ID
2017/2088
Acronym
AcuSpA
Status last verified
Jan 2025
First submitted
16 Jan 2018
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meng CF, Wang D, Ngeow J, Lao L, Peterson M, Paget S. Acupuncture for chronic low back pain in older patients: a randomized, controlled trial. Rheumatology (Oxford). 2003 Dec;42(12):1508-17. doi: 10.1093/rheumatology/keg405. Epub 2003 Jul 30.

    PubMed 12890859

  • Kwan YH, Fong W, Ang XL, Chew XY, Yoon S, Tan CS, Tai BC, Huang Y, Bilger M, Phang JK, Tan HC, Quek SA, Eng SYC, Tan CT, Dong BQ, Koh HL, Leung YY, Ng SC, Fong KY, Thumboo J, Ostbye T. Facilitators of and barriers to implementing a traditional Chinese medicine collaborative model of care for axial spondyloarthritis: a qualitative study. Acupunct Med. 2021 Dec;39(6):629-636. doi: 10.1177/09645284211009543. Epub 2021 May 28.

    PubMed 34049443

  • Kwan YH, Fong W, Ang XL, Tan CS, Tai BC, Huang Y, Bilger M, Phang JK, Tan HC, Lee JV, Sun L, Tan CT, Dong BQ, Koh HL, Leung YY, Lui NL, Yeo SI, Ng SC, Fong KY, Thumboo J, Ostbye T. Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial. Trials. 2019 Jan 14;20(1):46. doi: 10.1186/s13063-018-3117-2.

    PubMed 30642381

Questions about this trial

What is this clinical trial studying?

A study testing TCM physician involved collaborative care model (TCMCMC) in people with Axial Spondyloarthritis, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean difference in spinal pain score (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03420404, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in