Clinical Trial of TCM Collaborative Care Model in Axial Spondyloarthritis

NCT03420404 | Active Not Recruiting DMC

• 1 other identifier: 2017/2088
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Mean difference in spinal pain score

  Mean difference in spinal pain score between intervention and control groups at week 6 of treatment.

  Baseline, Week 6

Secondary Outcomes (10)

• Mean difference in spinal pain score

  Baseline, Week 12, Week 24

• Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, Week 6, Week 12, Week 24

• Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)

  Baseline, Week 6, Week 12, Week 24

• Mean difference in Bath Ankylosing Spondylitis Global score (BAS-G)

  Baseline, Week 6, Week 12, Week 24

• Mean difference in Health Assessment Questionnaire (HAQ)

  Baseline, Week 6, Week 12, Week 24

Other Outcomes (10)

• Mean difference in spinal pain score

  Baseline, Week 52

• Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, Week 52

• Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI)

  Baseline, Week 52

Study Arms (2)

Collaborative care with TCM physicians

EXPERIMENTAL

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)

Usual care only

NO INTERVENTION

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

Interventions

TCM physician involved collaborative care model (TCMCMC) OTHER

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.

Collaborative care with TCM physicians

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator
• Saw Swee Hock School of Public Health: collaborator
• National University of Singapore: collaborator
• Thong Chai Medical Institute Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

Location

Related Publications (3)

• 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.

  PMID: 12890859 RESULT

• 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.

  PMID: 34049443 DERIVED

• 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.

  PMID: 30642381 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Warren Fong

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The rheumatologist will be blinded for the first 6 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 5, 2018
• Study Start: March 5, 2018
• Primary Completion: December 30, 2024
• Study Completion: December 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)