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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Studying of Acupuncture for Bell's Palsy According to Different Stages

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Bell's Palsy Paralysis

U.S. FDA Resources

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 ]

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

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

Locations

China, Sichuan
Chengdu university of TCM
Chengdu, Sichuan, China, 610075

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 by Chengdu University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	LiYing, Acupuncture & Tuina college of chengdu univeristy of TCM
ClinicalTrials.gov Identifier:	NCT00608660 History of Changes
Other Study ID Numbers:	2006BAI12B03
Study First Received:	January 4, 2008
Last Updated:	September 15, 2009
Health Authority:	China: Ethics Committee

Keywords provided by Chengdu University of Traditional Chinese Medicine:

Peripheral Facial Paralysis
Acupuncture
RCT

Additional relevant MeSH terms:

Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases

Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012