Status:
UNKNOWN
Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Duke-NUS Graduate Medical School
National University of Singapore
Conditions:
Spondylarthritis
Axial Spondyloarthritis
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
Axial spondyloarthritis (AxSpA) is a chronic disease that causes severe disability and poor quality of life. Current treatment options are limited and there are still significant non-responders to cur...
Detailed Description
Patients with active axial spondyloarthritis despite non-steroidal anti-inflammatory drugs (NSAIDs) or biologics, will be randomly allocated to receive electroacupuncture or manual acupuncture on a 1:...
Eligibility Criteria
Inclusion
- Aged 21 years of age or older
- Diagnosed with AxSpA according to the 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria
- Bath AS Disease Activity Index (BASDAI) score ≥4 on a 11-point Numerical Rating Scale (NRS)
- Failed 2 sequential NSAIDs (including cyclooxygenase-2 inhibitor) at maximal tolerated doses for ≥4 weeks in total
- Patients on concomitant biological therapy (e.g. tumour necrosis factor inhibitor therapy, anti-interleukin 17) or non-biologic disease-modifying antirheumatic drugs (DMARDs) (e.g. methotrexate (MTX) or sulfasalazine (SSZ) or leflunomide (LEF)) at study entry must be on the drug for ≥12 weeks and at stable dose for ≥4 weeks prior to randomisation
- Patients taking systemic corticosteroids have to be on stable dose of ≤10mg/day prednisolone or equivalent for at least two weeks before randomisation.
Exclusion
- Pregnant or breastfeeding women
- With bleeding disorders
- With blood-borne communicable diseases (e.g. hepatitis B, hepatitis C, human immunodeficiency virus, etc)
- With implantable electrical device (e.g. pacemaker)
- Suffering from impaired skin sensation or serious skin lesions along the vertebrae
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04519866
Start Date
February 24 2021
End Date
December 1 2025
Last Update
December 26 2023
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608