Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

— AcuSpA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03420404
• Other study ID #: 2017/2088
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Singapore General Hospital
• Contact: Warren Fong
• Phone: +65 63214028
• Email: warren.fong.w.s[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

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.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
Singapore General Hospital	Duke-NUS Graduate Medical School, National University of Singapore, Saw Swee Hock School of Public Health, Thong Chai Medical Institute Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Mean difference in BASDAI score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)	Mean difference in BASFI score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.	Week 52
Other	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 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in Health Assessment Questionnaire (HAQ)	Mean difference in HAQ score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.	Week 52
Other	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 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)	Mean difference in ASQoL score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in Rheumatologist's consultation fees	Mean difference in rheumatologist's consultation fees scores between intervention and control groups at week 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in costs of laboratory procedures	Mean difference in costs of laboratory procedures between intervention and control groups at week 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in number of inpatient days	Mean difference in number of inpatient days between intervention and control groups at week 52 of treatment will serve as exploratory outcome.	Week 52
Other	Mean difference in spinal pain score	Mean difference in spinal pain score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.	Week 52
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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