Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Primary Purpose
Bell Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Facial PNF technique
Massage therapy
Sponsored by
About this trial
This is an interventional other trial for Bell Palsy
Eligibility Criteria
Inclusion Criteria: Both males and females with age between 20 to 50 years All patients diagnosed with Bell's palsy Non traumatic onset Acute onset 1 to 3 weeks Either right or left side Exclusion Criteria: Subject who have other Neurological disorder Subjects who have impaired cognition Complete paralysis of face Open wound on face
Sites / Locations
- Al Nafees Medical Hospital, Islamabd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
massage therapy will be given to this group of participants
Facial PNFtechnique will be given to this group of participants
Outcomes
Primary Outcome Measures
Sunnybrook facial grading scale
complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal
Facial Clinimetric Evaluation Scale
to evaluate the impairment and disability associated with facial weakness. It is calculated ranging from 0 (worst) to 100 (best)
Secondary Outcome Measures
Full Information
NCT ID
NCT05679752
First Posted
December 15, 2022
Last Updated
March 10, 2023
Sponsor
Neuro Counsel Hospital, Pakistan
Collaborators
Al Nafees Medical Hospital, Islamabad, Reliance Hospital Rawalpindi
1. Study Identification
Unique Protocol Identification Number
NCT05679752
Brief Title
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Official Title
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuro Counsel Hospital, Pakistan
Collaborators
Al Nafees Medical Hospital, Islamabad, Reliance Hospital Rawalpindi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effects of Massage therapy and Facial PNF in early Bell's palsy
Detailed Description
It is an interventional study in which investigator will give massage therapy to one group of patients and facial PNF techniques to other group to evaluate the efficacy of these intervention on bell's palsy pateints
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trail
Masking
Participant
Masking Description
single blind RCT in which just participants do not know in which group they are being treated
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
massage therapy will be given to this group of participants
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Facial PNFtechnique will be given to this group of participants
Intervention Type
Other
Intervention Name(s)
Facial PNF technique
Other Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
Stimulation techniques used to facilitate the weak muscle groups
Intervention Type
Other
Intervention Name(s)
Massage therapy
Other Intervention Name(s)
Passive massage
Intervention Description
frictional massage to stimulate the weak muscle groups
Primary Outcome Measure Information:
Title
Sunnybrook facial grading scale
Description
complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal
Time Frame
assessment will be done after 6 weeks
Title
Facial Clinimetric Evaluation Scale
Description
to evaluate the impairment and disability associated with facial weakness. It is calculated ranging from 0 (worst) to 100 (best)
Time Frame
assessment will be done after 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both males and females with age between 20 to 50 years
All patients diagnosed with Bell's palsy
Non traumatic onset
Acute onset 1 to 3 weeks
Either right or left side
Exclusion Criteria:
Subject who have other Neurological disorder
Subjects who have impaired cognition
Complete paralysis of face
Open wound on face
Facility Information:
Facility Name
Al Nafees Medical Hospital, Islamabd
City
Islamabad
State/Province
Federally Administered Tribal...
ZIP/Postal Code
44010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Still not decided about this.
Learn more about this trial
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
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