SpondylarthritisE-AcuSpANCT04519866
Clinical Trial of Electroacupuncture in Axial Spondyloarthritis (E-AcuSpA)
A study testing Electroacupuncture and Manual acupuncture in people with Spondylarthritis and Axial Spondyloarthritis, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Spondylarthritis, Axial Spondyloarthritis
- What is being tested?
- Electroacupuncture and Manual acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Feb 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Lay Lian Tan
About this study
Official title: A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
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.
Read the 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.
- Conditions
- Spondylarthritis, Axial Spondyloarthritis
- Being tested
- Electroacupuncture, Manual acupuncture
- Keywords
- Acupuncture, Electroacupuncture, Manual acupuncture
- Medical subject headings
- Spondylarthritis, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
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 acupunctureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | 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. Receives: Other: Electroacupuncture |
| Manual acupuncture | Active comparator | 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. Receives: Other: Manual acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 3, 6, 9, 12
Secondary outcomes (8)
Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups
Mean difference in BASFI score between both groups from baseline to weeks 6, 12 and 24.
BASFI score ranges from 0-10, with higher scores indicating poorer functioning.
Measured: Week 6, 12, 24
Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups
Mean difference in BAS-G score between both groups from baseline to weeks 6, 12 and 24.
BAS-G score ranges from 0-10, with higher scores reflecting poorer well-being.
Measured: Week 6, 12, 24
Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) score between both groups
Mean difference in ASAS HI score between both groups from baseline to weeks 6, 12 and 24.
ASAS HI score ranges from 0-17, with higher scores indicating poorer health status.
Measured: Week 6, 12, 24
Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) score between both groups
Mean difference in ASQoL score between both groups from baseline to weeks 6, 12 and 24.
ASQoL score ranges from 0-18, with higher scores indicating worse quality of life.
Measured: Week 6, 12, 24
Mean difference in EuroQol- 5 Dimension (EQ-5D) score between both groups
Mean difference in EQ-5D score between both groups from baseline to weeks 6, 12 and 24.
EQ-5D consists of a descriptive system and a visual analogue scale. The descriptive system covers 5 dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. Each dimension has a minimum and maximum score of 1 and 5 respectively, with higher scores representing a greater problem in that dimension. The visual analogue scale ranges from 0-100, with lower scores indicating poorer health status.
Measured: Week 6, 12, 24
Mean difference in Work Productivity and Activity Impairment (WPAI) score between both groups
Mean difference in WPAI score between both groups from baseline to weeks 6, 12 and 24.
WPAI measures absenteeism, presenteeism, work productivity loss and activity impairment. These are expressed as percentages, from 0-100, with higher numbers indicating greater impairment and less productivity.
Measured: Week 6, 12, 24
Mean difference in healthcare costs between both groups
Mean difference in healthcare costs will be assessed for both groups at weeks 6, 12 and 24.
Measured: Week 6, 12, 24
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 week 24. BASDAI score ranges from 0-10, with higher scores indicating higher disease activity.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start24 Feb 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, National University of Singapore, Thong Chai Institute of Medical Research
- Responsible party
- Sponsor
- Investigators
- Warren Fong, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519866
- Sponsor's protocol ID
- 2019/2435
- Acronym
- E-AcuSpA
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2020
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30642381
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Electroacupuncture in the Management of Patients With Axial Spondyloarthritis in Singapore (E-AcuSpA)
- ClinicalTrials.gov ID
- NCT04519866
- Acronym / sponsor ID
- E-AcuSpA / 2019/2435
- Conditions
- Spondylarthritis, Axial Spondyloarthritis
- Keywords
- Acupuncture, Electroacupuncture, Manual acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, National University of Singapore, Thong Chai Institute of Medical Research
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Other: ElectroacupunctureIn 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. |
| Manual acupuncture | Active comparator | Other: Manual acupunctureIn 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureManual 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. | Other | Electroacupuncture |
| Manual acupunctureAfter 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). | Other | Manual acupuncture |
Primary outcome
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
Time frame: 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.
8 secondary outcomes
Mean difference in Bath Ankylosing Spondylitis Functional Index (BASFI) score between both groups
Time frame: Week 6, 12, 24
Mean difference in Bath Ankylosing Spondylitis Patient Global score (BAS-G) between both groups
Time frame: Week 6, 12, 24
Mean difference in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) score between both groups
Time frame: Week 6, 12, 24
Mean difference in Ankylosing Spondylitis Quality of Life (ASQoL) score between both groups
Time frame: Week 6, 12, 24
Mean difference in EuroQol- 5 Dimension (EQ-5D) score between both groups
Time frame: Week 6, 12, 24
Mean difference in Work Productivity and Activity Impairment (WPAI) score between both groups
Time frame: Week 6, 12, 24
Mean difference in healthcare costs between both groups
Time frame: Week 6, 12, 24
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Background: PubMed 30642381Kwan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Fong principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Manual acupuncture in people with Spondylarthritis and Axial Spondyloarthritis, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Warren Fong (+65 63214028, warren.fong.w.s@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score between both groups (time frame: Week 3, 6, 9, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.