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

This study has been completed.
Sponsor:
Information provided by:
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00608660
First received: January 4, 2008
Last updated: September 15, 2009
Last verified: September 2009
History of Changes
  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:

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):

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 May 19, 2013