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

Primary Purpose

Bell's Palsy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture, deqi
acupuncture Non-manipulation
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy focused on measuring Bell's palsy，deqi，acupuncture, neuropsychology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Integrated Traditional Chinese and Western Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture with Deqi

Acupuncture without Deqi

Arm 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.

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

Outcomes

Primary Outcome Measures

House-Brackmann scale (HBS)

Secondary Outcome Measures

facial disability index (FDI)
World Health Organization Quality of Life-BREF(WHOQOL-BREF)

Full Information

First Posted
May 23, 2008
Last Updated
September 28, 2011
Sponsor
Huazhong University of Science and Technology
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT00685789
Brief Title
Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy
Acronym
ADAPT
Official Title
Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell's Palsy
Keywords
Bell's palsy，deqi，acupuncture, neuropsychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture with Deqi
Arm Type
Experimental
Arm 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.
Arm Title
Acupuncture without Deqi
Arm Type
Active Comparator
Arm Description
Needles were simply inserted and retained for 30 min, without any other stimulation.
Intervention Type
Device
Intervention Name(s)
acupuncture, deqi
Other Intervention Name(s)
Manipulation
Intervention Description
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
Intervention Type
Device
Intervention Name(s)
acupuncture Non-manipulation
Other Intervention Name(s)
Non-Manipulation
Intervention Description
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
Primary Outcome Measure Information:
Title
House-Brackmann scale (HBS)
Time Frame
6 months after onset of symptoms
Secondary Outcome Measure Information:
Title
facial disability index (FDI)
Time Frame
6 months after onset of symptoms
Title
World Health Organization Quality of Life-BREF(WHOQOL-BREF)
Time Frame
6 months after onset of symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Wang, doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Integrated Traditional Chinese and Western Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23439629
Citation
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.
Results Reference
derived

Learn more about this trial

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

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