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

September 15, 2009 updated by: Chengdu University of Traditional Chinese Medicine

Studying of Acupuncture for Bell's Palsy According to Different Stages

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
staging acupuncture for treating Bell's Palsy
Other: acupuncture
staging acupuncture
Other: acupuncture
non-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
staging acupuncture
Other: acupuncture
non-staging acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
House-Brackmann scale （Global Score）
Time Frame: a week
a week

Secondary Outcome Measures

Outcome Measure
Time Frame
Classification Score Of Facial Paralysis Degree
Time Frame: a week
a week
Facial Disability Index
Time Frame: a week
a week
WHOQOL-BREF scale
Time Frame: two week
two week
House-Brackmann scale （Regional Score）
Time Frame: a week
a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Ying Li, Dr., Acupuncture&Moxibustion college of chengdu TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (ESTIMATE)

February 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 15, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI12B03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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