Clinical trial NCT04519866: Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)
Official title: A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spondylarthritis
Axial Spondyloarthritis
Keywords: Acupuncture
Electroacupuncture
Manual acupuncture
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
name: National University of Singapore
name: Thong Chai Institute of Medical Research
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 1:1 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.

Eligibility 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

Primary outcomes:
measure: Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
timeFrame: Week 3, 6, 9, 12
Secondary outcomes:
measure: Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) score between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) score between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in EuroQol- 5 Dimension (EQ-5D) score between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in Work Productivity and Activity Impairment (WPAI) score between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in healthcare costs between both groups
timeFrame: Week 6, 12, 24
measure: Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
timeFrame: Week 24
Other outcomes:
measure: Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
timeFrame: Week 52
measure: Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups
timeFrame: Week 52
measure: Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups
timeFrame: Week 52
measure: Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) score between both groups
timeFrame: Week 52
measure: Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) score between both groups
timeFrame: Week 52
measure: Mean difference in EuroQol- 5 Dimension (EQ-5D) score between both groups
timeFrame: Week 52
measure: Mean difference in Work Productivity and Activity Impairment (WPAI) score between both groups
timeFrame: Week 52
measure: Mean difference in healthcare costs will be assessed for both groups
timeFrame: Week 52
measure: Mean difference in Traditional Chinese Medicine (TCM) syndrome scores will be assessed for both groups
timeFrame: Week 3, 6, 9, 12
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Warren Fong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.