Intratympanic Steroid for Bell's Palsy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/28/2018 |
| Start Date: | January 31, 2018 |
| End Date: | December 2020 |
| Contact: | Rebecca I Schneider, MS |
| Email: | schneiderri@health.missouri.edu |
| Phone: | 573-882-2549 |
Intratympanic Steroid Injection for Treatment of Idiopathic Facial Nerve Paralysis
Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for
facial nerve paralysis is a 10 day course of oral steroids (which will reduce the
inflammation), with electrodiagnostic testing. There have been limited studies on the use of
intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve
paralysis. There are indications that the use of intratympanic injections, in addition to the
oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as
improve the complete recovery of the facial nerve paralysis. This study will randomize
patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral
steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a
subset of patients that are unable to take oral steroids for medical reasons (such as
diabetes); these patients will be placed into a third group and only receive 3 intratympanic
steroid injections space out over three weeks. Subjects that are to receive the intratympanic
injection will receive pre- and post-hearing exams as part of their standard of care.
Patients will be evaluated via videorecording by two blinded investigators as well as in
person evaluations by the unblinded treating physician.
Subjects will be followed until complete facial nerve paralysis recovery or one year
post-treatment, whichever comes first.
facial nerve paralysis is a 10 day course of oral steroids (which will reduce the
inflammation), with electrodiagnostic testing. There have been limited studies on the use of
intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve
paralysis. There are indications that the use of intratympanic injections, in addition to the
oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as
improve the complete recovery of the facial nerve paralysis. This study will randomize
patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral
steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a
subset of patients that are unable to take oral steroids for medical reasons (such as
diabetes); these patients will be placed into a third group and only receive 3 intratympanic
steroid injections space out over three weeks. Subjects that are to receive the intratympanic
injection will receive pre- and post-hearing exams as part of their standard of care.
Patients will be evaluated via videorecording by two blinded investigators as well as in
person evaluations by the unblinded treating physician.
Subjects will be followed until complete facial nerve paralysis recovery or one year
post-treatment, whichever comes first.
Facial nerve paralysis is due to inflammation surrounding the facial nerve. Current clinical
practice guidelines for treatment of facial nerve paralysis recommend a 10 day course of oral
steroids +/- oral acyclovir. Treatment should begin within 72 hours of symptom onset. In
patients with complete facial paralysis, electrodiagnostic testing should be offered to the
patient (1-2). In patients with 90% degeneration on electroneuronography (ENoG) testing,
facial nerve decompression may be considered but is not a current recommendation.
In 1973, Bryant reported on ten cases where intratympanic steroid injection was used for the
treatment of Bell's palsy (3). All but one of these patients had complete recovery of their
facial nerve function. The remaining patient had 75% recovery. None of these patients
suffered complications from the injections. The next study published on intratympanic steroid
injection for Bell's palsy was not published until 2014 (4). It was a randomized control
trial that divided patients into standard treatment (oral steroids and acyclovir) versus
standard treatment with intratympanic steroid injection. There was not a statistically
significant difference between the complete recovery rate of the control group and of the
intratympanic steroid group; however, the time to recovery was significantly shorter in the
intratympanic steroid injection group as compared to the control group. Limitations of this
study include small sample size and high attrition rate.
There have not been any other studies published in the literature looking at improving facial
nerve recovery in idiopathic facial nerve paralysis with the use of intratympanic steroid
injections.
practice guidelines for treatment of facial nerve paralysis recommend a 10 day course of oral
steroids +/- oral acyclovir. Treatment should begin within 72 hours of symptom onset. In
patients with complete facial paralysis, electrodiagnostic testing should be offered to the
patient (1-2). In patients with 90% degeneration on electroneuronography (ENoG) testing,
facial nerve decompression may be considered but is not a current recommendation.
In 1973, Bryant reported on ten cases where intratympanic steroid injection was used for the
treatment of Bell's palsy (3). All but one of these patients had complete recovery of their
facial nerve function. The remaining patient had 75% recovery. None of these patients
suffered complications from the injections. The next study published on intratympanic steroid
injection for Bell's palsy was not published until 2014 (4). It was a randomized control
trial that divided patients into standard treatment (oral steroids and acyclovir) versus
standard treatment with intratympanic steroid injection. There was not a statistically
significant difference between the complete recovery rate of the control group and of the
intratympanic steroid group; however, the time to recovery was significantly shorter in the
intratympanic steroid injection group as compared to the control group. Limitations of this
study include small sample size and high attrition rate.
There have not been any other studies published in the literature looking at improving facial
nerve recovery in idiopathic facial nerve paralysis with the use of intratympanic steroid
injections.
Inclusion Criteria:
- English as primary language
- Acute unilateral facial palsy without skin lesions which developed within a 72-hour
period and is present for 21 days or less.
- Moderate to severe facial palsy [House-Brackmann grade IV or greater]
Exclusion Criteria:
- Another cause of facial nerve paralysis that is not idiopathic
- Otologic disease including otitis media, temporal bone fracture, a previous history of
facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay
Hunt syndrome.
- Systemic disease including history of tuberculosis, history of head and neck cancer,
other neurological disorders, recent use of ototoxic medications, liver or renal
dysfunction, and other illnesses that would contraindicate the use of high-dose
steroid therapy.
- Pregnancy
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