- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260310
The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis
March 31, 2017 updated by: Yang Min, Chengdu PLA General Hospital
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Sichuan
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Chengdu city, Sichuan, China, 610083
- 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA,
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weizhong and Huantiao
Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points
|
|
|
Active Comparator: A-shi point
Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
Time Frame: At 0 week, 6 weeks, 12 weeks
|
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
|
At 0 week, 6 weeks, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
October 3, 2014
First Submitted That Met QC Criteria
October 8, 2014
First Posted (Estimate)
October 9, 2014
Study Record Updates
Last Update Posted (Actual)
April 4, 2017
Last Update Submitted That Met QC Criteria
March 31, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BL40GB30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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