Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
Information source: Assiut University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Facial Palsy
Intervention: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Assiut University
Summary
The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in
complete recovery of 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
submitted to the following clinical evaluation using House and Brackmann6 facial function
scoring system and Synnybrook grading system neurophysiological assessment of facial nerve
and muscles before and after the end of treatment and then after the end of first and second
month of treatment. EMG will be 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 to be significant in
terms of poor prognosis. Nerve conduction study of facial nerves of both sides using
concentric needle electrode. Trigeminal Blink reflex for both side of the face. Facial
functional recovery was defined as "good" or "complete" using the same criteria used in the
2001 practice guideline. Using the House and Brackmann6 facial function scoring system, we
considered an outcome of grade I or II a good recovery.
Clinical Details
Official title: Antiviral Treatment in Facial Palsy. Randomized Control Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Facial muscle function using clinical scale
Secondary outcome: Nerve conduction study of facial nerve.
Eligibility
Minimum age: 15 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2013
Last updated: December 26, 2014
|