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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bell's Palsy

Intervention / Treatment
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* Device: acupuncture, deqi
* Device: acupuncture Non-manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms; aged 18 to 65 years. Exclusion criteria： illiterate; the facial paralysis is caused by herpes zoster; recurrent facial paralysis; noticeable asymmetry of the face before the illness which may affect the evaluation; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture with Deqi<br>Needles were inserted and manipulated manually using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation of soreness, numbness, fullness, aching, cool, warmth, heaviness and radiating sensation (Deqi) occurred. The needles were retained for 30 min. | Device: acupuncture, deqi<br>* Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.<br>* Other names: Manipulation;|
| Active Comparator: Acupuncture without Deqi<br>Needles were simply inserted and retained for 30 min, without any other stimulation. | Device: acupuncture Non-manipulation<br>* After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.<br>* Other names: Non-Manipulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| House-Brackmann scale (HBS) |  | 6 months after onset of symptoms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| facial disability index (FDI) |  | 6 months after onset of symptoms | 
| World Health Organization Quality of Life-BREF(WHOQOL-BREF) |  | 6 months after onset of symptoms | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bell's palsy，deqi，acupuncture, neuropsychology