Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis (AcuSpA)

November 19, 2025 updated by: Singapore General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
    • Singapore
      • Singapore, Singapore, Singapore, 169608
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Collaborative care with TCM physicians
TCM 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.
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.
No Intervention: Usual care only
The attending rheumatologist will prescribe a variety of treatment inclusive of medications such as non-steroidal anti-inflammatory drugs and physiotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12, Week 24
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.
Baseline, Week 6, Week 12, Week 24
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.
Baseline, Week 6, Week 12, Week 24
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.
Baseline, Week 6, Week 12, Week 24
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.
Baseline, Week 6, Week 12, Week 24
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.
Baseline, Week 6, Week 12, Week 24
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.
Baseline, Week 6, Week 12, Week 24
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.
Week 6, Week 12, Week 24
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.
Week 6, Week 12, Week 24
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.
Week 6, Week 12, Week 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 52
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.
Baseline, Week 52
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.
Baseline, Week 52
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.
Baseline, Week 52
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.
Baseline, Week 52
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.
Baseline, Week 52
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.
Baseline, Week 52
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.
Baseline, Week 52
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.
Week 52
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.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singapore General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke-NUS Graduate Medical School
Saw Swee Hock School of Public Health
Thong Chai Medical Institute Singapore
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Warren Fong, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/2088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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