Ankylosing SpondylitisNCT02260310
The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis
A study testing Weizhong and Huantiao and A-shi point in people with Ankylosing Spondylitis, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of acupuncture protocol involving in Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Weizhong and Huantiao and A-shi point
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jan 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible adult (≥18 years of age) patients
- had a diagnosis of AS for at least 3 months defined as definite by the 1984 modified New York criteria
- Eligible patients also had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of ≥4 (0-10 cm scale)
- A visual analogue scale (VAS) score for total back pain of ≥4 (0-10 cm scale)
Who cannot join
- Had received prior Acupuncture therapy
- With complete ankylosis of the spine, defined as the presence of bridging syndesmophytes at all intervertebral levels of the cervical and lumbar spine on lateral view spinal radiographs
Trial locations and contacts
1 site in 1 country.
China1 site
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
Chengdu, Sichuan, 610083
About this study
The purpose of this study is to evaluate the effect of acupuncture protocol involving in Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Weizhong and Huantiao, A-shi point
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weizhong and HuantiaoOther
A-shi pointOther
| Study group | Role | What they receive |
|---|---|---|
| Weizhong and Huantiao | Experimental | Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points Receives: Other: Weizhong and Huantiao |
| A-shi point | Active comparator | Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points Receives: Other: A-shi point |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
Measured: At 0 week, 6 weeks, 12 weeks
Change from Baseline in Visual Analog Scale at 12 weeks
Measured: At 0 week, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260310
- Sponsor's protocol ID
- BL40GB30
- Status last verified
- Mar 2017
- First submitted
- 3 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02260310
- Acronym / sponsor ID
- BL40GB30
- Conditions
- Ankylosing Spondylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Oct 2014 (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.
The purpose of this study is to evaluate the effect of acupuncture protocol involving in Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weizhong and Huantiao | Experimental | Other: Weizhong and HuantiaoPatients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points |
| A-shi point | Active comparator | Other: A-shi pointPatients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible adult (≥18 years of age) patients
- had a diagnosis of AS for at least 3 months defined as definite by the 1984 modified New York criteria
- Eligible patients also had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of ≥4 (0-10 cm scale)
- A visual analogue scale (VAS) score for total back pain of ≥4 (0-10 cm scale)
Key exclusion criteria (2 listed)
- Had received prior Acupuncture therapy
- With complete ankylosis of the spine, defined as the presence of bridging syndesmophytes at all intervertebral levels of the cervical and lumbar spine on lateral view spinal radiographs
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 |
|---|---|---|
| Weizhong and Huantiao | Other | Weizhong and Huantiao |
| A-shi point | Other | A-shi point |
Primary outcome
Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
Time frame: At 0 week, 6 weeks, 12 weeks
Change from Baseline in Visual Analog Scale at 12 weeks
Time frame: At 0 week, 6 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weizhong and Huantiao and A-shi point in people with Ankylosing Spondylitis, run by Chengdu PLA General Hospital at 1 site in China.
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 2 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 4 Apr 2017. 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 China. 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?
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 from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks (time frame: At 0 week, 6 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.