Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
Condition: Facial Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis; Facies
Study type: Interventional

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
    

Intervention name(s): Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir)
Intervention MeSH terms: Acyclovir; Antiviral Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Facial Palsy (acute), Acyclovir, Prednisolone