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

Huazhong University of Science and Technology

Status: Completed

Conditions: Bell's Palsy

Treatments: Device: acupuncture, deqi; Device: acupuncture Non-manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00685789

2006CB504502

Details and patient eligibility

About

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

Full 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.

Enrollment: 355 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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355 participants in 2 patient groups

Acupuncture with Deqi

Experimental group

Description:

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.

Treatment:

Device: acupuncture, deqi

Acupuncture without Deqi

Active Comparator group

Description:

Needles were simply inserted and retained for 30 min, without any other stimulation.

Treatment:

Device: acupuncture Non-manipulation