Electroacupuncture for treating axial spondyloarthritis
A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
This study is testing whether electroacupuncture is more effective and safe than manual acupuncture for people with active axial spondyloarthritis who haven't found relief from regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 100 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04519866 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness, safety, and cost-effectiveness of electroacupuncture versus manual acupuncture in patients with active axial spondyloarthritis who have not responded adequately to standard medications. Participants will be randomly assigned to receive either treatment while continuing their standard care, and their disease activity will be monitored over 12 weeks. The primary outcome will be measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), with additional assessments for quality of life and cost-effectiveness. The study will also track adverse events to ensure safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older diagnosed with axial spondyloarthritis who have not responded to multiple NSAIDs.
Not a fit: Patients who are pregnant, breastfeeding, or have bleeding disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from axial spondyloarthritis.
How similar studies have performed: Previous studies have shown that acupuncture can reduce pain in similar conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Warren Fong — Singapore General Hospital
- Study coordinator: Warren Fong
- Email: warren.fong.w.s@singhealth.com.sg
- Phone: +65 63214028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.