NCT00685789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 29, 2011

Status Verified

June 1, 2008

Enrollment Period

2 years

First QC Date

May 23, 2008

Last Update Submit

September 28, 2011

Conditions

Bell's Palsy

Keywords

Bell's palsy，deqi，acupuncture, neuropsychology

Outcome Measures

Primary Outcomes (1)

  • House-Brackmann scale (HBS)

    6 months after onset of symptoms

Secondary Outcomes (2)

  • 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

Study Arms (2)

Acupuncture with Deqi

EXPERIMENTAL

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

Acupuncture without Deqi

ACTIVE COMPARATOR

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

Device: acupuncture Non-manipulation

Interventions

acupuncture, deqiDEVICE

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

Also known as: Manipulation
Acupuncture with Deqi
acupuncture Non-manipulationDEVICE

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

Also known as: Non-Manipulation
Acupuncture without Deqi

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Integrated Traditional Chinese and Western Medicine

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • 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.

    PMID: 23439629DERIVED

MeSH Terms

Conditions

Bell Palsy

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Wei Wang, doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurology of Tongji Hospital

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

September 29, 2011

Record last verified: 2008-06

Locations

CN(1)