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Completed

NCT Number: NCT00685789

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Integrated Traditional Chinese and Western Medicine

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture, deqi

Device

Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.

Other names: Manipulation

acupuncture Non-manipulation

Device

After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Other names: Non-Manipulation

Primary outcomes

  1. House-Brackmann scale (HBS)

    Time frame: 6 months after onset of symptoms

Secondary outcomes

  1. facial disability index (FDI)

    Time frame: 6 months after onset of symptoms

  2. World Health Organization Quality of Life-BREF(WHOQOL-BREF)

    Time frame: 6 months after onset of symptoms

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Fudan University
  • Hubei Hospital of Traditional Chinese Medicine
  • Renmin Hospital of Wuhan University
  • Second Affiliated Hospital of Zhengzhou University
  • The First Hospital of Hebei Medical University
  • Wuhan General Hospital of Guangzhou Military Command
  • Wuhan No.1 Hospital
  • Xiangyang No.1 People's Hospital
  • Yichang Hospital of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: ADAPT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 28, 2008
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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