Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
Primary Purpose
Facial Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)
Sponsored by
About this trial
This is an interventional treatment trial for Facial Palsy focused on measuring Facial Palsy (acute), Acyclovir, Prednisolone
Eligibility Criteria
Inclusion Criteria:
- Acute onset facial palsy within the first three days of onset. Age ranged from 15-60 years old
Exclusion Criteria:
- Patients with brittle diabetes mellitus, Morbid obesity, renal or liver impairment, osteopenia, prior history of steroid intolerance.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Steroid Group
Steroid + Antiviral Group
Arm Description
prednisolone 60 mg /day IM /IV for 6 consecutive days then reduced by 10 mg /day (for a total treatment time for 12 days)
Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days)
Outcomes
Primary Outcome Measures
Facial muscle function using clinical scale
Evaluations of facial muscle function using clinical scale were performed blindly by a neurologist who was unaware of the type of treatment of which the patient had received
Secondary Outcome Measures
Nerve conduction study of facial nerve.
Measurment of facial n. coduction
Full Information
NCT ID
NCT02328079
First Posted
December 10, 2014
Last Updated
September 12, 2020
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT02328079
Brief Title
Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
Official Title
Antiviral Treatment in Facial Palsy. Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscles was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system
Detailed Description
The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscle was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Palsy
Keywords
Facial Palsy (acute), Acyclovir, Prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Steroid Group
Arm Type
Active Comparator
Arm Description
prednisolone 60 mg /day IM /IV for 6 consecutive days then reduced by 10 mg /day (for a total treatment time for 12 days)
Arm Title
Steroid + Antiviral Group
Arm Type
Active Comparator
Arm Description
Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days)
Intervention Type
Drug
Intervention Name(s)
Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)
Other Intervention Name(s)
Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir)
Intervention Description
Group allocations: Steroid group (prednisolone 60 mg /day IM /IV), Steroid plus Antiviral group (Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days) were placed in serially-numbered opaque closed envelopes. Each patient was placed in the appropriate group after opening the corresponding sealed envelope.
Primary Outcome Measure Information:
Title
Facial muscle function using clinical scale
Description
Evaluations of facial muscle function using clinical scale were performed blindly by a neurologist who was unaware of the type of treatment of which the patient had received
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Nerve conduction study of facial nerve.
Description
Measurment of facial n. coduction
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute onset facial palsy within the first three days of onset. Age ranged from 15-60 years old
Exclusion Criteria:
Patients with brittle diabetes mellitus, Morbid obesity, renal or liver impairment, osteopenia, prior history of steroid intolerance.
12. IPD Sharing Statement
Citations:
PubMed Identifier
27689547
Citation
Khedr EM, Badry R, Ali AM, Abo El-Fetoh N, El-Hammady DH, Ghandour AM, Abdel-Haleem A. Steroid/Antiviral for the treatment of Bell's palsy: Double blind randomized clinical trial. Restor Neurol Neurosci. 2016 Nov 22;34(6):897-905. doi: 10.3233/RNN-150605.
Results Reference
derived
Learn more about this trial
Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
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