Synkinesis is one of the most unpleasant squeal of peripheral facial nerve palsy. It refers to the abnormal involuntary facial movement accompanying the voluntary movement of a different facial muscle group.The aim of this study was to investigate the efficacy of biofeedback and Botulinum A Toxin injection to improve synkinesis and symmetry in facial nerve palsy. The sequel of facial nerve palsy will be included. Upper motor neuron lesion, hemifacial spasm and bilateral facial nerve palsy will be excluded. 30 subjects with facial nerve palsy were randomly divided into two groups. The first group will receive Botulinum toxin A injection around the mouth and eye (synkinesis area). The control group, will take part in four-months rehabilitation program including Neuromuscular reeducation by biofeedback immediately after saline injection as a placebo. All subjects will be evaluated by facial grading system and video type. The final evaluation will be conducted four months after treatment. The Both groups will be compared using facial grading system.(Sunny Brook system).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612136083N10
Registration date:2017-03-14, 1395/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-14, 1395/12/24
Registrant information
Name
Abbas Ali Pourmomeny
Name of organization / entity
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2024
Email address
pourmomeny@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor's Office for Research in Isfahan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy neuromuscular Retraining and Botox in sequel of facial nerve palsy
Public title
Treatment sequel of facial nerve palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: incomplete recovery facial nerve palsy ; Asymmetry in facial muscles during Expression
Exclusion : upper motor neuron lesion ; Bilateral facial nerve palsy ; hamifacial spasm palsy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2016-04-26, 1395/02/07
Ethics committee reference number
IR.MUI.REC.1395.3.128
Health conditions studied
1
Description of health condition studied
Facial palsy
ICD-10 code
G51.0
ICD-10 code description
Bell palsy
Primary outcomes
1
Description
Synkinesis
Timepoint
Before treatment
Method of measurement
Vedio type & sunny Brook Scale(facial grading scale)
2
Description
Asymmetry face
Timepoint
Before treatment
Method of measurement
Vedio type & sunny Brook Scale(facial grading scale)
Secondary outcomes
1
Description
Synkinesis
Timepoint
After treatment
Method of measurement
Vedio type & facial grading scale
2
Description
Asymmetry
Timepoint
After treatment
Method of measurement
Vedio type & facial grading scale
Intervention groups
1
Description
biofeedback group:Neuromuscular retraining for 4 months
Category
Treatment - Drugs
2
Description
botox A group: 15- 20 unite toxin type A (Dysport) injections in the face (around the synkinesis muscles)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Pourmomeny
Street address
Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor's Office In Isfahan University of Medical Sciences
Full name of responsible person
Dr.Nematbaghsh
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor's Office In Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Pourmomeny
Position
Acadmic member
Other areas of specialty/work
Street address
School of Rehabilitation ,Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 5018
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Pourmomeny
Position
Instuctor
Other areas of specialty/work
Street address
Isfahan Univercity of Medical Sciences
City
School of Rehabilitation ,Isfahan University of Medical Sciences
Postal code
Phone
+98 31 3792 5018
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abbas Ali Pourmomeny
Position
Planer/designer
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Postal code
Phone
+98 31 3792 5018
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)