Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy

NCT02328079 | Completed DMC

• 1 other identifier: Antiviral in facial palsy
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Facial Palsy

Keywords

Facial Palsy (acute), Acyclovir, Prednisolone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nerve conduction study of facial nerve.

  2 months

Study Arms (2)

Steroid Group

ACTIVE COMPARATOR

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)

Steroid + Antiviral Group

ACTIVE COMPARATOR

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)

Interventions

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

Also known as: Steroid group (Prednisolone), Steroid plus Antiviral group (Prednisolone + acyclovir)

Steroid + Antiviral Group; Steroid Group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Acute onset facial palsy within the first three days of onset. Age ranged from 15-60 years old

You may not qualify if:

• Patients with brittle diabetes mellitus, Morbid obesity, renal or liver impairment, osteopenia, prior history of steroid intolerance.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 27689547 DERIVED

MeSH Terms

Conditions

Facial Paralysis

Interventions

Steroids; Prednisolone; Antiviral Agents; Acyclovir

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 31, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 16, 2020

Record last verified: 2020-09