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

This study has been completed.
Sponsor:
Collaborators:
Hubei Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Xiangyang No.1 People's Hospital
Renmin Hospital of Wuhan University
Fudan University
The Second Affiliated Hospital, Zhengzhou University
Yichang Hospital of Traditional Chinese Medicine
Hebei Medical University First Hospital
Wuhan General Hospital of Guangzhou Command PLA
Information provided by (Responsible Party):
Wei Wang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00685789
First received: May 23, 2008
Last updated: September 28, 2011
Last verified: June 2008
History of Changes
  Purpose

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


Condition Intervention
Bell's Palsy
 Device: acupuncture, deqi
Device: acupuncture Non-manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • House-Brackmann scale (HBS) [ Time Frame: 6 months after onset of symptoms ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • facial disability index (FDI) [ Time Frame: 6 months after onset of symptoms ] [ Designated as safety issue: No ]
  • World Health Organization Quality of Life-BREF(WHOQOL-BREF) [ Time Frame: 6 months after onset of symptoms ] [ Designated as safety issue: No ]

Enrollment: 355
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture with Deqi
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
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
Other Name: Manipulation
Active Comparator: Acupuncture without Deqi
Needles were simply inserted and retained for 30 min, without any other stimulation.
 Device: acupuncture Non-manipulation
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
Other Name: Non-Manipulation

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685789

Locations
China, Hubei
Institute of Integrated Traditional Chinese and Western Medicine
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Hubei Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Xiangyang No.1 People's Hospital
Renmin Hospital of Wuhan University
Fudan University
The Second Affiliated Hospital, Zhengzhou University
Yichang Hospital of Traditional Chinese Medicine
Hebei Medical University First Hospital
Wuhan General Hospital of Guangzhou Command PLA
Investigators
Principal Investigator: Wei Wang, doctor Huazhong University of Science and Technology
  More Information

No publications provided by Huazhong University of Science and Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wei Wang, Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT00685789     History of Changes
Other Study ID Numbers: 2006CB504502
Study First Received: May 23, 2008
Last Updated: September 28, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Huazhong University of Science and Technology:
Bell's palsy，deqi，acupuncture, neuropsychology

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
 Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013