Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy

Study Overview
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Brief Summary
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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
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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

Official Title
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Antiviral Treatment in Facial Palsy. Randomized Control Trial

Conditions
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Facial Palsy

Intervention / Treatment
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* Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid Group<br>prednisolone 60 mg /day IM /IV for 6 consecutive days then reduced by 10 mg /day (for a total treatment time for 12 days) | Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)<br>* 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.<br>* Other names: Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir);|
| Active Comparator: Steroid + Antiviral Group<br>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) | Drug: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)<br>* 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.<br>* Other names: Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction study of facial nerve. | Measurment of facial n. coduction | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Palsy (acute), Acyclovir, Prednisolone