Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)
NCT ID: NCT04519866
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-02-24
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electroacupuncture
In addition to usual rheumatological care, patients in the electroacupuncture arm will undergo 2 courses of electroacupuncture treatment. Each treatment course will consist of 10 acupuncture sessions held over 5 weeks. Patient will take a break of 5-7 days in between each course of acupuncture.
Electroacupuncture
Manual acupuncture (see procedures below) will be administered first to obtain the "de qi" sensation. After "de qi" is obtained, the electroacupuncture unit will be connected to 1-3 pairs of acupoints. Current intensity used will be based on the tolerance of each patient. Needles with electrical stimulation will be retained for 30 min.
Main acupoints will be Jingjin points (meridian sinews) along the Bladder meridian of Foot - Taiyang, such as Shenshuci, as well as Jingjin points (meridian sinews) at transverse process from L2 to L4, iliac crest and spinous process from S1 to S4. Secondary acupoints will also be selected based on patients' syndromes and symptoms.
Manual acupuncture
In addition to usual rheumatological care, patients in the manual acupuncture arm will undergo 2 courses of manual acupuncture treatment. Each treatment course will consist of 10 acupuncture sessions held over 5 weeks. Patient will take a break of 5-7 days in between each course of acupuncture.
Manual acupuncture
After disinfecting the acupuncture points, acupuncture will be performed with the patient lying prone. Depending on the acupuncture points, 0.25mm X 25-75 mm sterile acupuncture needle will be used. Needles will be inserted 10-50 mm and either rotating manipulation or lifting-thrusting manipulation will be used to achieve "de qi" (a compositional sensation including soreness, numbness, distention and heaviness).
Acupoints used will be similar to those mentioned for electroacupuncture (see above).
Interventions
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Electroacupuncture
Manual acupuncture (see procedures below) will be administered first to obtain the "de qi" sensation. After "de qi" is obtained, the electroacupuncture unit will be connected to 1-3 pairs of acupoints. Current intensity used will be based on the tolerance of each patient. Needles with electrical stimulation will be retained for 30 min.
Main acupoints will be Jingjin points (meridian sinews) along the Bladder meridian of Foot - Taiyang, such as Shenshuci, as well as Jingjin points (meridian sinews) at transverse process from L2 to L4, iliac crest and spinous process from S1 to S4. Secondary acupoints will also be selected based on patients' syndromes and symptoms.
Manual acupuncture
After disinfecting the acupuncture points, acupuncture will be performed with the patient lying prone. Depending on the acupuncture points, 0.25mm X 25-75 mm sterile acupuncture needle will be used. Needles will be inserted 10-50 mm and either rotating manipulation or lifting-thrusting manipulation will be used to achieve "de qi" (a compositional sensation including soreness, numbness, distention and heaviness).
Acupoints used will be similar to those mentioned for electroacupuncture (see above).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
100 Years
ALL
No
Sponsors
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Duke-NUS Graduate Medical School
OTHER
National University of Singapore
OTHER
Thong Chai Institute of Medical Research
OTHER
Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Warren Fong
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Lay Lian Tan
Role: primary
References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2019/2435
Identifier Type: -
Identifier Source: org_study_id