Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)

  • STATUS
    Recruiting
  • End date
    Sep 9, 2024
  • participants needed
    100
  • sponsor
    Singapore General Hospital
Updated on 9 March 2021

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 current western medications. Manual acupuncture has been shown to reduce pain in patients with AxSpA. There have been reports of electroacupuncture demonstrating more sustained pain relief. Therefore, the investigators aim to determine the clinical effectiveness, safety and cost-effectiveness of electroacupuncture as compared to manual acupuncture for patients with AxSpA through a randomized controlled trial.

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 1:1 basis via random permuted block randomization. All patients will receive their standard of care (drug therapy and physiotherapy) as background therapy. This study will not be investigating any therapeutic or medicinal products (drugs).

Primary outcome would be the mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between the 2 groups over 12 weeks (as assessed at weeks 0, 3, 6, 9, 12) adjusted for baseline covariate and other potential confounders. Patients will be followed up for BASDAI, other clinical, quality of life (QoL), economic outcomes as well as Traditional Chinese Medicine (TCM) syndrome scores over time for secondary and exploratory outcomes. A cost-effectiveness analysis will be performed. Adverse events will be recorded.

The primary hypothesis is that electroacupuncture may result in better disease activity control in patients with AxSpA as compared to manual acupuncture over 12 weeks, while secondary hypothesis is that electroacupuncture may result in greater improvements in other clinical and quality of life outcomes as compared to those receiving manual acupuncture over 24 weeks. The investigators also hypothesize that there is no difference in safety between both arms.

Details
Condition Spondylarthritis, Spondyloarthropathy, Arthritis, Arthritis and Arthritic Pain, Axial Spondyloarthritis, Arthritis and Arthritic Pain (Pediatric), spondyloarthritis
Treatment Electroacupuncture, Manual acupuncture
Clinical Study IdentifierNCT04519866
SponsorSingapore General Hospital
Last Modified on9 March 2021

Eligibility

Yes No Not Sure

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
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