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

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ClinicalTrials.gov Identifier: NCT03420404
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
Duke-NUS Graduate Medical School
Saw Swee Hock School of Public Health
National University, Singapore
Thong Chai Medical Institute Singapore
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease Intervention/treatment
Axial Spondyloarthritis Other: TCM physician involved collaborative care model (TCMCMC)

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: The rheumatologist will be blinded for the first 6 weeks.
Primary Purpose: Treatment
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)
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Usual care only
The attending rheumatologist will prescribe a variety of treatment inclusive of medications such as non-steroidal anti-inflammatory drugs and physiotherapy.



Primary Outcome Measures :
  1. Mean difference in spinal pain score [ Time Frame: Week 6 ]
    Mean difference in spinal pain score between intervention and control groups from baseline to week 6 of treatment


Secondary Outcome Measures :
  1. Mean difference in spinal pain score [ Time Frame: Week 12, week 24 ]
    Mean difference in spinal pain score between intervention and control groups from baseline to week 12 and week 24 of treatment.

  2. Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    Mean difference in BASDAI score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.

  3. Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    Mean difference in BASFI score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.

  4. Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    Mean difference in BAS-G score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.

  5. Mean difference in Health Assessment Questionnaire (HAQ) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    Mean difference in HAQ score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.

  6. Mean difference in 36-Item Short Form Survey (SF-36) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    Mean difference in SF-36 score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.

  7. Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) [ Time Frame: Baseline, week 6, week 12, week 24 ]
    Mean difference in AsQoL score between intervention and control groups from baseline to week 6, week 12 and week 24 of treatment.

  8. Mean difference in rheumatologist's consultation fees [ Time Frame: Week 6, week 12, week 24 ]
    Mean difference in rheumatologist's consultation fees between intervention and control groups at week 6, week 12 and week 24 of treatment.

  9. Mean difference in costs of laboratory procedures [ Time Frame: Week 6, week 12, week 24 ]
    Mean difference in costs of laboratory procedures between intervention and control groups at week 6, week 12 and week 24 of treatment.

  10. Mean difference in number of inpatient days [ Time Frame: Week 6, week 12, week 24 ]
    Mean difference in number of inpatient days between intervention and control groups at week 6, week 12 and week 24 of treatment.


Other Outcome Measures:
  1. Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Week 52 ]
    Mean difference in BASDAI score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.

  2. Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Week 52 ]
    Mean difference in BASFI score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.

  3. Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G) [ Time Frame: Week 52 ]
    Mean difference in BAS-G score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.

  4. Mean difference in Health Assessment Questionnaire (HAQ) [ Time Frame: Week 52 ]
    Mean difference in HAQ score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.

  5. Mean difference in 36-Item Short Form Survey (SF-36) [ Time Frame: Week 52 ]
    Mean difference in SF-36 score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.

  6. Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) [ Time Frame: Week 52 ]
    Mean difference in ASQoL score between intervention and control groups from baseline to week 52 of treatment will serve as exploratory outcome.

  7. Mean difference in Rheumatologist's consultation fees [ Time Frame: Week 52 ]
    Mean difference in rheumatologist's consultation fees scores between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  8. Mean difference in costs of laboratory procedures [ Time Frame: Week 52 ]
    Mean difference in costs of laboratory procedures between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  9. Mean difference in number of inpatient days [ Time Frame: Week 52 ]
    Mean difference in number of inpatient days between intervention and control groups at week 52 of treatment will serve as exploratory outcome.

  10. Mean difference in spinal pain score [ Time Frame: Week 52 ]
    Mean difference in spinal pain score between intervention and control groups at week 52 of treatment will serve as exploratory outcome.



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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 10-point Numerical Rating Scale (NRS) and spinal pain score ≥4 on a 10-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
  • No concomitant disease-modifying antirheumatic drug (DMARD) therapy or corticosteroid therapy is allowed

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420404


Contacts
Contact: Warren Fong +65 63214028 warren.fong.w.s@singhealth.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Lay Lian Tan         
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School
Saw Swee Hock School of Public Health
National University, Singapore
Thong Chai Medical Institute Singapore
Investigators
Principal Investigator: Warren Fong Singapore General Hospital
  Study Documents (Full-Text)

Documents provided by Singapore General Hospital:

Publications:
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03420404     History of Changes
Other Study ID Numbers: 2017/2088
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases