A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
时间窗: Week 3, 6, 9, 12
Mean difference in BASDAI score between both groups from baseline to weeks 3, 6, 9 and 12. BASDAI score ranges from 0-10, with higher scores indicating higher disease activity.
次要结局
- Mean difference in healthcare costs between both groups(Week 6, 12, 24)
- Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) score between both groups(Week 6, 12, 24)
- Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups(Week 24)
- Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups(Week 6, 12, 24)
- Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) score between both groups(Week 6, 12, 24)
- Mean difference in EuroQol- 5 Dimension (EQ-5D) score between both groups(Week 6, 12, 24)
- Mean difference in Work Productivity and Activity Impairment (WPAI) score between both groups(Week 6, 12, 24)
- Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups(Week 6, 12, 24)