Clinical trial NCT02328079: Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
Official title: Antiviral Treatment in Facial Palsy. Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Palsy
Keywords: Facial Palsy (acute), Acyclovir, Prednisolone
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Facial muscle function using clinical scale
timeFrame: 2 months
Secondary outcomes:
measure: Nerve conduction study of facial nerve.
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
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.