Comparative effectiveness of Cranial Nerve Seventh (VII) Mobilization versus Manual Manipulation of facial muscles for improving muscular movement and Synkinesis among Bell’s palsy patients; Randomized Clinical Trial
To compare the effectiveness of Cranial Nerve VII mobilization and manual manipulation of facial muscles among patients of acute Bell’s palsy and to improve the voluntary movements of facial muscles and to reduce Synkinesis among patients.
Design
A randomized, single blinded, clinical trial with a parallel group design of 26 patients, enrolled between July 2024 and October 2024
Settings and conduct
The patients were recruited from the Aziz Fatima Hospital Faisalabad, Nusrat Abdul Rauf Center for Enablement Faisalabad and Madinah Teaching Hospital Faisalabad. It was a single blinded trail in which patients were blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 15-45 y/o, acute stage, HBG scale gradeⅡ-Ⅲ, SB facial grading score ≥40.
Exclusion criteria: Diagnosed Neurodegenerative Disorders, Diagnosed intra-cranial Tumors, Diagnosed Viral infection, Presence of severe comorbidities
Intervention groups
Both groups received superficial heat therapy, nerve stimulation and facial muscle exercises with addition of Manual Manipulation of facial muscles (which are supplied by Cranial Nerve VII) in Group A and Cranial Nerve VII Mobilization technique in Group B.
Main outcome variables
The primary outcome to be achieved from this study includes voluntary movement, Synkinesis and facial expressions.
The secondary outcome includes the facial symmetry.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240726062547N1
Registration date:2024-10-01, 1403/07/10
Registration timing:registered_while_recruiting
Last update:2024-10-01, 1403/07/10
Update count:0
Registration date
2024-10-01, 1403/07/10
Registrant information
Name
Aleena Shabbir
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
dpt-fa19-064@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-29, 1403/05/08
Expected recruitment end date
2024-10-29, 1403/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness of Cranial Nerve Seventh (VII) Mobilization versus Manual Manipulation of facial muscles for improving muscular movement and Synkinesis among Bell’s palsy patients; Randomized Clinical Trial
Public title
Cranial Nerve Seventh (VII) Mobilization versus Manual Manipulation of facial muscles for Bell’s palsy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute stage (onset within first week).
House Brackmann grading scale score gradeⅡ-Ⅲ (mild to moderate).
Sunny Brook facial grading scale score ≥40 (mild to moderate).
Diagnosed unilateral Bell’s palsy by clinical and neurological assessment.
No previous history of Bell’s palsy and stroke.
Diagnosed Bell’s palsy pt receiving standard drug treatment (SDT).
No previous History of physiotherapy treatment sessions for Bell’s palsy.
Exclusion criteria:
Diagnosed Neurodegenerative Disorders (Multiple sclerosis, Myasthenia gravis and Guillain-Barre syndrome).
Diagnosed intra cranial Tumors(55), parotid gland tumors(56),facial nerve schwannomas (56)and squamous cell carcinoma.
Diagnosed Viral infection (herpes simplex, herpes zoster).
Diagnosed for more than 14 days.
Multiple episodes (more than 1) of Bell’s palsy.
Presence of severe comorbidities (diabetes, hypertension) that could impact the implementation of the treatment and performance.
Diagnosed Traumatic injury to the 7th cranial nerve.
Pacemakers or implanted electrical devices.
Unwilling to participate in the study.
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
A computer software called Online randomize generator was used. the software generated a random sequence. Allocation concealment was carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blinded in the study as they did not know which group were they being allocated to. Group allocation sequence was selected by a computer software called online randomize generator.
Placebo
Not used
Assignment
Parallel
Other design features
A clinical trial to find out better effective treatment protocol for bell's palsy patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Institutional Review Board
Street address
Gulistan colony no.1, W.E block, House no.5, Faisalabad, Pakistan
City
Faisalabad
Postal code
38610
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
TUF/IRB/394/24
Health conditions studied
1
Description of health condition studied
Bell's palsy
ICD-10 code
G51.0
ICD-10 code description
Bell's palsy
Primary outcomes
1
Description
Voluntary movement
Timepoint
Before intervention and after 15th session
Method of measurement
House-Brackmann grading scale
2
Description
Synkinesis
Timepoint
Before intervention and after 15th session
Method of measurement
Sunny Brook Facial Grading Scale
3
Description
Facial expressions
Timepoint
Before intervention and after 15th session
Method of measurement
Sunny Brook Facial Grading Scale
Secondary outcomes
1
Description
Symmetry of face
Timepoint
Before intervention and after 15th session
Method of measurement
Sunnybrook Facial Grading Scale
Intervention groups
1
Description
Intervention group: Manual Manipulation of facial muscles group
Category
Treatment - Other
2
Description
Intervention group: Cranial Nerve seventh (VII) Mobilization group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Aziz Fatima Hospital
Full name of responsible person
Dr. Basit Mahmood
Street address
Raja Road, Gulistan Colony no. 1, Faisalabad, Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 41 8780910
Email
info@afh.com.pk
Web page address
https://afh.com.pk/
2
Recruitment center
Name of recruitment center
Nusrat Abdul Rauf Center for Enablement
Full name of responsible person
Prof. Shahid Ahmed Heera
Street address
Main Blvd, near Manzar Medical Center & Poly Clinic, D Ground Block D People's Colony No 1, Faisalabad, Pakistan