Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy

Bell's Palsy Clinical Trial

— ADAPT  

Official title:

Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685789
• Other study ID #: 2006CB504502
• Status: Completed
• Phase: N/A
• First received: May 23, 2008
• Last updated: September 28, 2011
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2008
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.

Description:

Through long-term clinical practice，acupuncture treatment on facial paralysis has been generally proved effective；the large number of ancient and modern medical literature also have suggested that acupuncture is beneficial for facial paralysis. However,a scientific basis is still needed to be established to make sure the efficacy of acupuncture be recognized internationally.This study will adopt a series of international practice scales ,such as House Brackmann Scale,Facial Disability Index(FDI),World Health Organization Quality of Life-BREF (WHOQOL-BREF), Cattell Personality Factors (16PF),and Cancellation test to evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for Bell's Palsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;

2. aged 18 to 65 years.

Exclusion criteria:

1. illiterate;

2. the facial paralysis is caused by herpes zoster;

3. recurrent facial paralysis;

4. noticeable asymmetry of the face before the illness which may affect the evaluation;

5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.

Study Design

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

Related Conditions & MeSH terms

• Bell Palsy
• Bell's Palsy
• Facial Paralysis

Intervention

Device:
• acupuncture, deqi
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
• acupuncture Non-manipulation
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Locations

Country	Name	City	State
China	Institute of Integrated Traditional Chinese and Western Medicine	Wuhan	Hubei

Sponsors (10)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Fudan University, Hebei Medical University First Hospital, Hubei Hospital of Traditional Chinese Medicine, Renmin Hospital of Wuhan University, Second Affiliated Hospital of Zhengzhou University, Wuhan General Hospital of Guangzhou Military Command, Wuhan No.1 Hospital, Xiangyang No.1 People's Hospital, Yichang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	House-Brackmann scale (HBS)		6 months after onset of symptoms	No
Secondary	facial disability index (FDI)		6 months after onset of symptoms	No
Secondary	World Health Organization Quality of Life-BREF(WHOQOL-BREF)		6 months after onset of symptoms	No