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Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages

Primary Purpose

Bell's Palsy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
acupuncture and moxibustion
electroacupuncture
acupuncture along yangming tendons
acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy focused on measuring Peripheral Facial Paralysis, Acupuncture, RCT

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients who meet the diagnosis, stages, location criteria
  • the first time to onset the disease
  • between 1 and 70 days with the onset time of facial palsy
  • on one side of the face paralysis
  • between 15 and 70 years old with the onset age of facial palsy
  • willing to finish the whole observation period
  • with written consent form signed by themselves.

Exclusion Criteria:

  • facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
  • facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
  • patient with Hunt's syndrome
  • patient with facial spasm
  • pregnant women or women in lactation
  • patients are participating other clinical research

Sites / Locations

  • Chengdu university of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

E

Arm Description

staging acupuncture for treating Bell's Palsy

staging acupuncture and moxibustion for treating Bell's Palsy

staging electroacupuncture for treating Bell's Palsy

staging acupuncture along Yangming musculature for treating Bell's Palsy

non-staging acupuncture for treating Bell's Palsy

Outcomes

Primary Outcome Measures

House-Brackmann scale （Global Score）

Secondary Outcome Measures

Classification Score Of Facial Paralysis Degree
Facial Disability Index
WHOQOL-BREF scale
House-Brackmann scale （Regional Score）

Full Information

First Posted
January 4, 2008
Last Updated
September 15, 2009
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00608660
Brief Title
Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages
Official Title
Studying of Acupuncture for Bell's Palsy According to Different Stages
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy
Detailed Description
The result of this trial (available in 2009) aims to testify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's Palsy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell's Palsy
Keywords
Peripheral Facial Paralysis, Acupuncture, RCT

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
staging acupuncture for treating Bell's Palsy
Arm Title
B
Arm Type
Experimental
Arm Description
staging acupuncture and moxibustion for treating Bell's Palsy
Arm Title
C
Arm Type
Experimental
Arm Description
staging electroacupuncture for treating Bell's Palsy
Arm Title
D
Arm Type
Experimental
Arm Description
staging acupuncture along Yangming musculature for treating Bell's Palsy
Arm Title
E
Arm Type
Experimental
Arm Description
non-staging acupuncture for treating Bell's Palsy
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
staging acupuncture
Intervention Type
Other
Intervention Name(s)
acupuncture and moxibustion
Intervention Description
staging acupuncture and moxibustion
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
staging electroacupuncture
Intervention Type
Other
Intervention Name(s)
acupuncture along yangming tendons
Intervention Description
staging acupuncture along Yangming musculature
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
non-staging acupuncture
Primary Outcome Measure Information:
Title
House-Brackmann scale （Global Score）
Time Frame
a week
Secondary Outcome Measure Information:
Title
Classification Score Of Facial Paralysis Degree
Time Frame
a week
Title
Facial Disability Index
Time Frame
a week
Title
WHOQOL-BREF scale
Time Frame
two week
Title
House-Brackmann scale （Regional Score）
Time Frame
a week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients who meet the diagnosis, stages, location criteria the first time to onset the disease between 1 and 70 days with the onset time of facial palsy on one side of the face paralysis between 15 and 70 years old with the onset age of facial palsy willing to finish the whole observation period with written consent form signed by themselves. Exclusion Criteria: facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis patient with Hunt's syndrome patient with facial spasm pregnant women or women in lactation patients are participating other clinical research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Li, Dr.
Organizational Affiliation
Acupuncture&Moxibustion college of chengdu TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chengdu university of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21435214
Citation
Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
Results Reference
derived

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Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages

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