Ankylosing SpondylitisNCT02697968
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis
A study testing Electroacupuncture in people with Ankylosing Spondylitis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2016to Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- with a diagnosis of AS and fulfilled either ASAS criteria or Modified New York criteria,
- Bath Ankylosing Spondylitis Disease Activity Index, BASDAI ≥4,
- currently taking analgesic or NSAIDs for pain control,
- spinal pain assessment score≥4 on a numerical rating scale (NRS; 0-10 scale)
Who cannot join
- having active skin lesion or open wound over the needle placement areas;
- having heart disease, bleeding disorder or taking anticoagulant drugs
- have previous acupuncture experience 12 months before the baseline,
- are pregnant, breast-feeding or of childbearing potential but not using adequate contraception;
- having psoriasis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis or reactive arthritis;
- having unstable medical condition such as liver and/or kidney failure or cancers.;
- concurrently taking or injecting steroid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study
Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Previous studies demonstrated acupuncture has significant therapeutic effects for AS in diminishing joint pain, enhancing functional disorders and modifying spinal deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence is very limited due to methodological flaws.
Design This study will be a single-arm pilot study in patients with AS. Eligible subjects will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in total) if participants request a prolonged treatment. The acupuncturist, who is a registered Chinese medicine practitioner, of this trial will not participate in data collection and data entry.
Read more
Objective: To explore the treatment effect of electroacupuncture for relieving pain in ankylosing spondylitis.
Setting: Hong Kong
Participants: 20 subjects with a diagnosis of ankylosing spondylitis
Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events
Data analysis All data will be double-entered and checked for consistency before conducting the analysis. Binomial test will be used to analyze the percentage of responders to treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the values of all continuous variables between baseline and post treatment. The population for safety analyses will include all subjects who receive at least one acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special attention will be given to those subjects who have discontinued treatment due to adverse events or who experience serious adverse events.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Electroacupuncture
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | Not described Receives: Device: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity Numerical Rating Scale (NRS)
Measured: week 0 and 6
Secondary outcomes (11)
Types and dosage of drug(s) intake
Measured: week 0, 2, 4, 6, 8, 10, 12, 14 and 18
Bath Ankylosing Spondylitis Functional Index (BASFI)
Measured: week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measured: week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Global Index (BASGI)
Measured: week 0, 6, 10 and 18
Quality of life of patients as evaluated by SF-36
Quality of life of patients will be measured.
Measured: week 0, 6, 10 and 18
Bath Ankylosing spondylitis Metrology Index (BASMI)
Measured: week 0, 6, 10 and 18
Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm
Measured: week 0, 6, 10 and 18
Joints count
Measured: week 0, 6, 10 and 18
C-reactive protein (CRP)
Measured: week 0, 6, 10 and 18
Erythrocyte sedimentation rate (ESR)
Measured: week 0, 6, 10 and 18
Change in Pain Severity Numerical Rating Scale (NRS)
Measured: week 0, 2, 4, 8, 10, 12, 14, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completionDec 2017
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 Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor LAO Lixing, The University of Hong Kong
- Investigators
- Lixing LAO, Ph.D., Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697968
- Sponsor's protocol ID
- UW 15-458
- Status last verified
- Sep 2019
- First submitted
- 24 Feb 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
Publications
Lam WL, Yeung WF, Lau CS, Jiang F, Chen H, Lao L. Electroacupuncture for the relief of suboptimally managed pain in ankylosing spondylitis: A single-arm pilot study. Acupunct Med. 2026 May 25:9645284261444761. doi: 10.1177/09645284261444761. Online ahead of print.
PubMed 42179340
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study
- ClinicalTrials.gov ID
- NCT02697968
- Acronym / sponsor ID
- UW 15-458
- Conditions
- Ankylosing Spondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Previous studies demonstrated acupuncture has significant therapeutic effects for AS in diminishing joint pain, enhancing functional disorders and modifying spinal deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence is very limited due to methodological flaws.
Design This study will be a single-arm pilot study in patients with AS. Eligible subjects will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in total) if participants request a prolonged treatment. The acupuncturist, who is a registered Chinese medicine practitioner, of this trial will not participate in data collection and data entry.
Objective: To explore the treatment effect of electroacupuncture for relieving pain in ankylosing spondylitis.
Setting: Hong Kong
Participants: 20 subjects with a diagnosis of ankylosing spondylitis
Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events
Data analysis All data will be double-entered and checked for consistency before conducting the analysis. Binomial test will be used to analyze the percentage of responders to treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the values of all continuous variables between baseline and post treatment. The population for safety analyses will include all subjects who receive at least one acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special attention will be given to those subjects who have discontinued treatment due to adverse events or who experience serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: Electroacupuncture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- with a diagnosis of AS and fulfilled either ASAS criteria or Modified New York criteria,
- Bath Ankylosing Spondylitis Disease Activity Index, BASDAI ≥4,
- currently taking analgesic or NSAIDs for pain control,
- spinal pain assessment score≥4 on a numerical rating scale (NRS; 0-10 scale)
Key exclusion criteria (7 listed)
- having active skin lesion or open wound over the needle placement areas;
- having heart disease, bleeding disorder or taking anticoagulant drugs
- have previous acupuncture experience 12 months before the baseline,
- are pregnant, breast-feeding or of childbearing potential but not using adequate contraception;
- having psoriasis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis or reactive arthritis;
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 |
|---|---|---|
| Electroacupuncture | Device | Electroacupuncture |
Primary outcome
Change in Pain Severity Numerical Rating Scale (NRS)
Time frame: week 0 and 6
11 secondary outcomes
Types and dosage of drug(s) intake
Time frame: week 0, 2, 4, 6, 8, 10, 12, 14 and 18
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: week 0, 6, 10 and 18
Bath Ankylosing Spondylitis Global Index (BASGI)
Time frame: week 0, 6, 10 and 18
Quality of life of patients as evaluated by SF-36
Time frame: week 0, 6, 10 and 18
Bath Ankylosing spondylitis Metrology Index (BASMI)
Time frame: week 0, 6, 10 and 18
Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm
Time frame: week 0, 6, 10 and 18
Joints count
Time frame: week 0, 6, 10 and 18
C-reactive protein (CRP)
Time frame: week 0, 6, 10 and 18
Erythrocyte sedimentation rate (ESR)
Time frame: week 0, 6, 10 and 18
Change in Pain Severity Numerical Rating Scale (NRS)
Time frame: week 0, 2, 4, 8, 10, 12, 14, and 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 42179340Lam WL, Yeung WF, Lau CS, Jiang F, Chen H, Lao L. Electroacupuncture for the relief of suboptimally managed pain in ankylosing spondylitis: A single-arm pilot study. Acupunct Med. 2026 May 25:9645284261444761. doi: 10.1177/09645284261444761. Online ahead of print.
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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.
Lixing LAO, Ph.D. principal investigator
The University of Hong Kong
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 in people with Ankylosing Spondylitis, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 23 Sep 2019. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity Numerical Rating Scale (NRS) (time frame: week 0 and 6). 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 NCT02697968, 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 23 Sep 2019.