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Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis (AcuSpA)

Primary Purpose

Axial Spondyloarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
TCM physician involved collaborative care model (TCMCMC)
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Collaborative care with TCM physicians

Usual care only

Arm Description

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.

The attending rheumatologist will prescribe a variety of treatment inclusive of medications such as non-steroidal anti-inflammatory drugs and physiotherapy.

Outcomes

Primary Outcome Measures

Mean difference in spinal pain score
Mean difference in spinal pain score between intervention and control groups from baseline to week 6 of treatment

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 16, 2018
Last Updated
April 11, 2023
Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School, Saw Swee Hock School of Public Health, National University of Singapore, Thong Chai Medical Institute Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03420404
Brief Title
Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School, Saw Swee Hock School of Public Health, National University of Singapore, Thong Chai Medical Institute Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Masking Description
The rheumatologist will be blinded for the first 6 weeks.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collaborative care with TCM physicians
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care only
Arm Type
No Intervention
Arm Description
The attending rheumatologist will prescribe a variety of treatment inclusive of medications such as non-steroidal anti-inflammatory drugs and physiotherapy.
Intervention Type
Other
Intervention Name(s)
TCM physician involved collaborative care model (TCMCMC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean difference in spinal pain score
Description
Mean difference in spinal pain score between intervention and control groups from baseline to week 6 of treatment
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Mean difference in spinal pain score
Description
Mean difference in spinal pain score between intervention and control groups from baseline to week 12 and week 24 of treatment.
Time Frame
Week 12, week 24
Title
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Mean difference in BASDAI score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.
Time Frame
Baseline, week 6, week 12, week 24
Title
Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Mean difference in BASFI score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.
Time Frame
Baseline, week 6, week 12, week 24
Title
Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)
Description
Mean difference in BAS-G score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.
Time Frame
Baseline, week 6, week 12, week 24
Title
Mean difference in Health Assessment Questionnaire (HAQ)
Description
Mean difference in HAQ score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.
Time Frame
Baseline, week 6, week 12, week 24
Title
Mean difference in 36-Item Short Form Survey (SF-36)
Description
Mean difference in SF-36 score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.
Time Frame
Baseline, week 6, week 12, week 24
Title
Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)
Description
Mean difference in AsQoL score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.
Time Frame
Baseline, week 6, week 12, week 24
Title
Mean difference in rheumatologist's consultation fees
Description
Mean difference in rheumatologist's consultation fees between intervention and control groups at week 6, week 12 and week 24 of treatment.
Time Frame
Week 6, week 12, week 24
Title
Mean difference in costs of laboratory procedures
Description
Mean difference in costs of laboratory procedures between intervention and control groups at week 6, week 12 and week 24 of treatment.
Time Frame
Week 6, week 12, week 24
Title
Mean difference in number of inpatient days
Description
Mean difference in number of inpatient days between intervention and control groups at week 6, week 12 and week 24 of treatment.
Time Frame
Week 6, week 12, week 24
Other Pre-specified Outcome Measures:
Title
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Mean difference in BASDAI score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Mean difference in BASFI score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)
Description
Mean difference in BAS-G score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in Health Assessment Questionnaire (HAQ)
Description
Mean difference in HAQ score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in 36-Item Short Form Survey (SF-36)
Description
Mean difference in SF-36 score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL)
Description
Mean difference in ASQoL score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in Rheumatologist's consultation fees
Description
Mean difference in rheumatologist's consultation fees scores between intervention and control groups at week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in costs of laboratory procedures
Description
Mean difference in costs of laboratory procedures between intervention and control groups at week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in number of inpatient days
Description
Mean difference in number of inpatient days between intervention and control groups at week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52
Title
Mean difference in spinal pain score
Description
Mean difference in spinal pain score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Warren Fong
Phone
+65 63214028
Email
warren.fong.w.s@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Fong
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lay Lian Tan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12890859
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.
Results Reference
result
PubMed Identifier
34049443
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.
Results Reference
derived
PubMed Identifier
30642381
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.
Results Reference
derived

Learn more about this trial

Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

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