NCT02260310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

October 3, 2014

Last Update Submit

March 31, 2017

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks

    At 0 week, 6 weeks, 12 weeks

  • Change from Baseline in Visual Analog Scale at 12 weeks

    At 0 week, 6 weeks, 12 weeks

Study Arms (2)

Weizhong and Huantiao

EXPERIMENTAL

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

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

Other: A-shi point

Interventions

Weizhong and HuantiaoOTHER
Weizhong and Huantiao
A-shi pointOTHER
A-shi point

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 9, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CN(1)