Clinical trial NCT03420404: Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Axial Spondyloarthritis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
name: Saw Swee Hock School of Public Health
name: National University of Singapore
name: Thong Chai Medical Institute Singapore
First posted: 2018-02-05
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mean difference in spinal pain score
timeFrame: Week 6
Secondary outcomes:
measure: Mean difference in spinal pain score
timeFrame: Week 12, week 24
measure: Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, week 6, week 12, week 24
measure: Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, week 6, week 12, week 24
measure: Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)
timeFrame: Baseline, week 6, week 12, week 24
measure: Mean difference in Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, week 6, week 12, week 24
measure: Mean difference in 36-Item Short Form Survey (SF-36)
timeFrame: Baseline, week 6, week 12, week 24
measure: Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: Baseline, week 6, week 12, week 24
measure: Mean difference in rheumatologist's consultation fees
timeFrame: Week 6, week 12, week 24
measure: Mean difference in costs of laboratory procedures
timeFrame: Week 6, week 12, week 24
measure: Mean difference in number of inpatient days
timeFrame: Week 6, week 12, week 24
Other outcomes:
measure: Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Week 52
measure: Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Week 52
measure: Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)
timeFrame: Week 52
measure: Mean difference in Health Assessment Questionnaire (HAQ)
timeFrame: Week 52
measure: Mean difference in 36-Item Short Form Survey (SF-36)
timeFrame: Week 52
measure: Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: Week 52
measure: Mean difference in Rheumatologist's consultation fees
timeFrame: Week 52
measure: Mean difference in costs of laboratory procedures
timeFrame: Week 52
measure: Mean difference in number of inpatient days
timeFrame: Week 52
measure: Mean difference in spinal pain score
timeFrame: Week 52
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Warren Fong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.