Axial Spondyloarthritis
Conditions
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.
Interventions
OTHERTCM 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.
Sponsors
Duke-NUS Graduate Medical School
Saw Swee Hock School of Public Health
National University of Singapore
Thong Chai Medical Institute Singapore
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The rheumatologist will be blinded for the first 6 weeks.
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in spinal pain score | Baseline, Week 6 | Mean difference in spinal pain score between intervention and control groups at week 6 of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in number of inpatient days | 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. |
| Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 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. |
| Mean difference in spinal pain score | Baseline, Week 12, Week 24 | Mean difference in spinal pain score between intervention and control groups at week 12 and week 24 of treatment. |
| Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) | 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. |
| Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G) | 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. |
| Mean difference in Health Assessment Questionnaire (HAQ) | 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. |
| Mean difference in 36-Item Short Form Survey (SF-36) | 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. |
| Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) | 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. |
| Mean difference in consultation fees (rheumatologist and other outpatient) and drugs | 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. |
| Mean difference in costs of laboratory procedures and imaging | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in spinal pain score | Baseline, Week 52 | Mean difference in spinal pain score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline, Week 52 | Mean difference in BASDAI score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline, Week 52 | Mean difference in BASFI score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G) | Baseline, Week 52 | Mean difference in BAS-G score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in Health Assessment Questionnaire (HAQ) | Baseline, Week 52 | Mean difference in HAQ score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in 36-Item Short Form Survey (SF-36) | Baseline, Week 52 | Mean difference in SF-36 score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) | Baseline, Week 52 | Mean difference in AsQoL score between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in consultation fees (rheumatologist and other outpatient) and drugs | Week 52 | Mean difference in consultation fees and drugs between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in number of inpatient days | Week 52 | Mean difference in number of inpatient days between intervention and control groups at week 52 of treatment will serve as exploratory outcome. |
| Mean difference in costs of laboratory procedures and imaging | 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. |
Countries
Singapore
Outcome results
None listed