Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

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.

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)

Conditions
-----------------
Axial Spondyloarthritis

Intervention / Treatment
-----------------
* Other: TCM physician involved collaborative care model (TCMCMC)


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative care with TCM physicians<br>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)<br>* 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.<br>|
| No Intervention: Usual care only<br>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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in spinal pain score | Mean difference in spinal pain score between intervention and control groups from baseline to week 6 of treatment | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in spinal pain score | Mean difference in spinal pain score between intervention and control groups from baseline to week 12 and week 24 of treatment. | Week 12, week 24 | 
| Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Mean difference in BASDAI score between intervention and control groups from baseline to 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) | Mean difference in BASFI score between intervention and control groups from baseline to 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) | Mean difference in BAS-G score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment. | Baseline, week 6, week 12, week 24 | 
| Mean difference in Health Assessment Questionnaire (HAQ) | Mean difference in HAQ score between intervention and control groups from baseline to 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) | Mean difference in SF-36 score between intervention and control groups from baseline to 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) | Mean difference in AsQoL score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment. | Baseline, week 6, week 12, week 24 | 
| Mean difference in rheumatologist's consultation fees | Mean difference in rheumatologist's consultation fees 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 | Mean difference in costs of laboratory procedures 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 | Mean difference in number of inpatient days between intervention and control groups at week 6, week 12 and week 24 of treatment. | Week 6, week 12, week 24 |