Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)
E-AcuSpA
A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
E-AcuSpA
A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
Sponsor study identifier
interventional
100
1 country
1
Study Start
February 24, 2021
Actual (reported)Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2020
Actual (reported)August 20, 2020
Actual (reported)February 24, 2021
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
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.
Week 3, 6, 9, 12
Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) 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
Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) 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 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
Week 52
Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups
Week 52
Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups
Week 52
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.
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 (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.
Singapore General Hospital
Singapore, 169608, Singapore
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.
Warren Fong
Singapore General Hospital
First Submitted
August 17, 2020
First Posted
August 20, 2020
Study Start
February 24, 2021
Actual (reported)Primary Completion
December 2024
Estimated (date passed)Dose-Effect Response in Acupuncture for Functional Constipation
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).
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 26, 2023
Record last verified: 2023-12
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