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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Singapore General Hospital
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Mean difference in spinal pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Masking Description
The rheumatologist will be blinded for the first 6 weeks.
Eligibility Criteria
- Ages
- 21 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: TCM physician involved collaborative care model (TCMCMC) (Other)
Usual care only
The attending rheumatologist will prescribe a variety of treatment inclusive of medications such as non-steroidal anti-inflammatory drugs and physiotherapy.
Outcomes
Primary Outcomes
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
- Mean difference in spinal pain score(Baseline, Week 12, Week 24)
- Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Week 6, Week 12, Week 24)
- Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, Week 6, Week 12, Week 24)
- Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)(Baseline, Week 6, Week 12, Week 24)
- Mean difference in Health Assessment Questionnaire (HAQ)(Baseline, Week 6, Week 12, Week 24)
- Mean difference in 36-Item Short Form Survey (SF-36)(Baseline, Week 6, Week 12, Week 24)
- Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)(Baseline, Week 6, Week 12, Week 24)
- Mean difference in consultation fees (rheumatologist and other outpatient) and drugs(Week 6, Week 12, Week 24)
- Mean difference in costs of laboratory procedures and imaging(Week 6, Week 12, Week 24)
- Mean difference in number of inpatient days(Week 6, Week 12, Week 24)