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

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ClinicalTrials.gov Identifier: NCT00608660
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:
Chengdu University of Traditional Chinese Medicine

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

Condition or disease Intervention/treatment Phase
Bell's Palsy Other: acupuncture Other: acupuncture and moxibustion Other: electroacupuncture Other: acupuncture along yangming tendons Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Studying of Acupuncture for Bell's Palsy According to Different Stages
Study Start Date : October 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. House-Brackmann scale (Global Score) [ Time Frame: a week ]

Secondary Outcome Measures :
  1. Classification Score Of Facial Paralysis Degree [ Time Frame: a week ]
  2. Facial Disability Index [ Time Frame: a week ]
  3. WHOQOL—BREF scale [ Time Frame: two week ]
  4. House-Brackmann scale (Regional Score) [ Time Frame: a week ]


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Peripheral Facial Paralysis
Acupuncture
RCT

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms