Clinical trial NCT00685789: Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy
Official title: Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell's Palsy
Keywords: Bell's palsy，deqi，acupuncture, neuropsychology
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Hubei Hospital of Traditional Chinese Medicine
name: Wuhan No.1 Hospital
name: Xiangyang No.1 People's Hospital
name: Renmin Hospital of Wuhan University
name: Fudan University
name: Second Affiliated Hospital of Zhengzhou University
name: Yichang Hospital of Traditional Chinese Medicine
name: The First Hospital of Hebei Medical University
name: Wuhan General Hospital of Guangzhou Military Command
First posted: 2008-05-28
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: House-Brackmann scale (HBS)
timeFrame: 6 months after onset of symptoms
Secondary outcomes:
measure: facial disability index (FDI)
timeFrame: 6 months after onset of symptoms
measure: World Health Organization Quality of Life-BREF(WHOQOL-BREF)
timeFrame: 6 months after onset of symptoms
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Institute of Integrated Traditional Chinese and Western Medicine
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Zhang GB, Xie MJ, Luo X, Huang GY, Wang W. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013 Apr 2;185(6):473-9. doi: 10.1503/cmaj.121108. Epub 2013 Feb 25.