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

Study of Effects of Deqi and Neuropsychological Factors on Acupuncture 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.

Study Overview

• Status: Completed
• Conditions: Bell's Palsy
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Institute of Integrated Traditional Chinese and Western Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Non-Manipulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Fudan University; Second Affiliated Hospital of Zhengzhou University; Renmin Hospital of Wuhan University; The First Hospital of Hebei Medical University; Hubei Hospital of Traditional Chinese Medicine; Wuhan No.1 Hospital; Wuhan General Hospital of Guangzhou Military Command; Yichang Hospital of Traditional Chinese Medicine; Xiangyang No.1 People's Hospital

Publications and helpful links

General Publications

• Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Zhang GB, Xie MJ, Luo X, Huang GY, Wang W. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013 Apr 2;185(6):473-9. doi: 10.1503/cmaj.121108. Epub 2013 Feb 25.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): September 29, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Bell's palsy，deqi，acupuncture, neuropsychology
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: 2006CB504502