NCT00608660

Brief Summary

The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

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

Study Start

First participant enrolled

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

2.9 years

First QC Date

January 4, 2008

Last Update Submit

September 15, 2009

Conditions

Keywords

Peripheral Facial ParalysisAcupunctureRCT

Outcome Measures

Primary Outcomes (1)

  • House-Brackmann scale (Global Score)

    a week

Secondary Outcomes (4)

  • Classification Score Of Facial Paralysis Degree

    a week

  • Facial Disability Index

    a week

  • WHOQOL-BREF scale

    two week

  • House-Brackmann scale (Regional Score)

    a week

Study Arms (5)

A

EXPERIMENTAL

staging acupuncture for treating Bell's Palsy

Other: acupuncture

B

EXPERIMENTAL

staging acupuncture and moxibustion for treating Bell's Palsy

Other: acupuncture and moxibustion

C

EXPERIMENTAL

staging electroacupuncture for treating Bell's Palsy

Other: electroacupuncture

D

EXPERIMENTAL

staging acupuncture along Yangming musculature for treating Bell's Palsy

Other: acupuncture along yangming tendons

E

EXPERIMENTAL

non-staging acupuncture for treating Bell's Palsy

Other: acupuncture

Interventions

staging acupuncture

A

staging acupuncture and moxibustion

B

staging electroacupuncture

C

staging acupuncture along Yangming musculature

D

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who meet the diagnosis, stages, location criteria
  • the first time to onset the disease
  • between 1 and 70 days with the onset time of facial palsy
  • on one side of the face paralysis
  • between 15 and 70 years old with the onset age of facial palsy
  • willing to finish the whole observation period
  • with written consent form signed by themselves.

You may not qualify if:

  • facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
  • facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
  • patient with Hunt's syndrome
  • patient with facial spasm
  • pregnant women or women in lactation
  • patients are participating other clinical research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu university of TCM

Chengdu, Sichuan, 610075, China

Location

Related Publications (1)

  • Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.

MeSH Terms

Conditions

Bell PalsyFacial Paralysis

Interventions

Acupuncture TherapyMoxibustionElectroacupuncture

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Ying Li, Dr.

    Acupuncture&Moxibustion college of chengdu TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

February 6, 2008

Study Start

October 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations