Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-11-30

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

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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

Conditions

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Facial Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Steroid Group

prednisolone 60 mg /day IM /IV for 6 consecutive days then reduced by 10 mg /day (for a total treatment time for 12 days)

Group Type ACTIVE_COMPARATOR

Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)

Intervention Type DRUG

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.

Steroid + 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)

Group Type ACTIVE_COMPARATOR

Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)

Intervention Type DRUG

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.

Interventions

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Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)

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.

Intervention Type DRUG