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

Bell's Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608660
• Other study ID #: 2006BAI12B03
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: September 15, 2009
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bell Palsy
• Bell's Palsy
• Facial Paralysis

Intervention

Other:
• acupuncture
staging acupuncture
• acupuncture and moxibustion
staging acupuncture and moxibustion
• electroacupuncture
staging electroacupuncture
• acupuncture along yangming tendons
staging acupuncture along Yangming musculature
• acupuncture
non-staging acupuncture

Locations

Country	Name	City	State
China	Chengdu university of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	House-Brackmann scale (Global Score)		a week	No
Secondary	Classification Score Of Facial Paralysis Degree		a week	No
Secondary	Facial Disability Index		a week	No
Secondary	WHOQOL—BREF scale		two week	No
Secondary	House-Brackmann scale (Regional Score)		a week	No