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The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Weizhong and Huantiao
A-shi point
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weizhong and Huantiao

A-shi point

Arm Description

Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points

Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points

Outcomes

Primary Outcome Measures

Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
Change from Baseline in Visual Analog Scale at 12 weeks

Secondary Outcome Measures

Full Information

First Posted
October 3, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02260310
Brief Title
The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weizhong and Huantiao
Arm Type
Experimental
Arm Description
Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points
Arm Title
A-shi point
Arm Type
Active Comparator
Arm Description
Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points
Intervention Type
Other
Intervention Name(s)
Weizhong and Huantiao
Intervention Type
Other
Intervention Name(s)
A-shi point
Primary Outcome Measure Information:
Title
Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
Time Frame
At 0 week, 6 weeks, 12 weeks
Title
Change from Baseline in Visual Analog Scale at 12 weeks
Time Frame
At 0 week, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
City
Chengdu city
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis

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