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

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ClinicalTrials.gov Identifier: NCT00685789
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : September 29, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Bell's Palsy Device: acupuncture, deqi Device: acupuncture 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy
Study Start Date : October 2008
Primary Completion Date : October 2010
Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. House-Brackmann scale (HBS) [ Time Frame: 6 months after onset of symptoms ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685789

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
Second Affiliated Hospital of Zhengzhou University
Yichang Hospital of Traditional Chinese Medicine
The First Hospital of Hebei Medical University
Wuhan General Hospital of Guangzhou Military Command
Principal Investigator: Wei Wang, doctor Tongji Hospital
More Information

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
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: June 2008

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

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