Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages - Full Text View

Sponsored by:	Chengdu University of Traditional Chinese Medicine
Information provided by:	Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00608660

Purpose

The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy

Condition	Intervention
Bell's Palsy	Other: acupuncture Other: acupuncture and moxibustion Other: electroacupuncture Other: acupuncture along yangming tendons

MedlinePlus related topics: Acupuncture Bell's Palsy Benign Tumors Paralysis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Studying of Acupuncture for Bell's Palsy According to Different Stages

Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:

House-Brackmann scale （Global Score） [ Time Frame: a week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Classification Score Of Facial Paralysis Degree [ Time Frame: a week ] [ Designated as safety issue: No ]
Facial Disability Index [ Time Frame: a week ] [ Designated as safety issue: No ]
WHOQOL—BREF scale [ Time Frame: two week ] [ Designated as safety issue: No ]
House-Brackmann scale （Regional Score） [ Time Frame: a week ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental staging acupuncture for treating Bell's Palsy	Other: acupuncture staging acupuncture
B: Experimental staging acupuncture and moxibustion for treating Bell's Palsy	Other: acupuncture and moxibustion staging acupuncture and moxibustion
C: Experimental staging electroacupuncture for treating Bell's Palsy	Other: electroacupuncture staging electroacupuncture
D: Experimental staging acupuncture along Yangming musculature for treating Bell's Palsy	Other: acupuncture along yangming tendons staging acupuncture along Yangming musculature
E: Experimental non-staging acupuncture for treating Bell's Palsy	Other: acupuncture non-staging acupuncture

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

Eligibility

Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608660

Contacts

Contact: Ying Li, Dr.

028-88044818

jialee@mail.sc.cninfo.net

Locations

China, Sichuan
Chengdu university of TCM	Recruiting
chengdu, Sichuan, China, 610075
Contact: Ying Li, Dr. 028-88044818 jialee@mail.sc.cninfo.net
Contact: Xiao-qin Chen, Master 13689011332 chenxiaqin_cdutcm@163.com
Principal Investigator: Ying Li, Dr.
Sub-Investigator: Xiao-qin Chen, Master

Sponsors and Collaborators

Chengdu University of Traditional Chinese Medicine

Investigators

Principal Investigator:

Ying Li, Dr.

Acupuncture&Moxibustion college of chengdu TCM

More Information

No publications provided

Responsible Party:	Acupuncture & Tuina college of chengdu univeristy of TCM ( LiYing )
Study ID Numbers:	2006BAI12B03
Study First Received:	January 4, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00608660 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Chengdu University of Traditional Chinese Medicine:

Peripheral Facial Paralysis
Acupuncture
RCT

Study placed in the following topic categories:

Mouth Diseases
Virus Diseases
Paralysis
Facies
Facial Nerve Diseases
Bell Palsy

DNA Virus Infections
Stomatognathic Diseases
Bell's Palsy
Facial Paralysis
Herpesviridae Infections

Additional relevant MeSH terms:

Mouth Diseases
Virus Diseases
Facial Nerve Diseases
Bell Palsy
Nervous System Diseases

DNA Virus Infections
Cranial Nerve Diseases
Stomatognathic Diseases
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009