Bell Palsy Clinical Trial
Official title:
Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial
Bell's palsy [BP] is defined as acute idiopathic peripheral facial palsy or paralysis.
Additional symptoms frequently include pain around or behind the ear, impaired tolerance to
ordinary levels of noise and disturbed sense of taste on the same side. It affects men and
women more or less equally.
There is a consensus in the literature regarding the importance of steroid treatment for
improving recovery rates and sequela of BP. Moreover, there is increasing level of high
quality of evidence in recent years for a combined antiviral and steroids treatment for
severe BP (House Brackmann [HB] 5-6).
Adverse effects (AEs) were reported in 1-12% of patients treated with steroids, antivirals or
placebo. The AEs reported were dyspepsia, loss of blood sugar control, headache, fatigue,
dizziness and insomnia, recurrent duodenal ulcers, mood swings, and acute psychosis. All
effects resolved when treatment was stopped.
Although steroid and antivirals are widely used for BP, there is a high variability of
steroids treatment, both in the dosage given and in the way of tapering down.
Among the different steroid regimens used were: prednisone 1 mg/kg for 5 days tapered to 10
mg/day for remaining 5 days; prednisone (1 mg/kg for 10 days then tapered to zero over the
next 6 days); prednisolone 60 mg for 5 days, 30 mg for 3 days, and 10 mg for 2 days.
House-Brackmann (HB) system is widely used for facial function assessment. It is based on a
six-grade score, where grade I is normal function, grade VI is complete absence of facial
motor function, and grades II to V are intermediate.
Steroid-induced side effects generally require tapering of the drug as soon as the disease
being treated is under control. Tapering must be done carefully to avoid both recurrent
activity of the underlying disease and possible cortisol deficiency resulting from
hypothalamic-pituitary-adrenal axis (HPA) suppression. However, according to a review by
Furst et al (2019), a patient who has received any dose of glucocorticoid for less than 3
weeks or patients treated with alternate-day prednisone at a dose of less than 10 mg (or its
equivalent) are unlikely for HPA suppression. They concluded that short-term glucocorticoid
therapy (up to three weeks), even if at a fairly high dose, can simply be stopped and need
not to be tapered..
According to the above, the investigators assume that a rapid withdrawal of steroids after
short course of treatment for BP should neither influence the efficacy or safety of
treatment.
Finally, steroid regimen may be hard to follow for some patients and can results in confusion
and frustration. Simplifying steroid regimen, such as skipping withdrawal if not necessary,
may solve this problem.
The objective of our study is to determine the effectiveness and safety of prednisone
treatment with no tapering down for Bell's Palsy.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | August 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Adult patients (=18 years) diagnosed with BP within 72 hour of onset. 2. Adult patients willing to get treatment, attending follow up visits and signing informed consent. Exclusion Criteria: 1. Patients treated with antivirals (i.e acyclovir) for any reason simultaneously, such as Herpes Zoster (Ramsay- Hunt syndrome). 2. Palsy onset > 72 hours before diagnosis or unknown onset. 3. Previous episodes of BP. 4. Patients suspected for hypothalamic-pituitary-adrenal (HPA) axis suppression who have to be cautiously tapered due to high risk for adrenal insufficiency: steroid treatment in any dosage for more the 3 weeks (due to other indication) or cushingoid appearance. 5. Contraindication for steroid use: uncontrolled diabetes or hypertension, psychosis, peptic ulcer or upper GI bleeding, liver cirrhosis or portal hypertension, known allergy to prednisone, etc. Any case in which steroid treatment was stopped earlier than planned by the patient or the physician. 6. Any conditions suspicious for non-idiopathic facial palsy: chronic otitis media, acute otitis media, mastoiditis, temporal bone/middle ear trauma, other cranial nerve neuropathies (i.e cranial nerve VIII), cerebrovascular disorders, tumor affecting facial nerve (i.e, parotid malignancy, schwannoma) or systemic causes (i.e multiple sclerosis, meningitis, sarcoidosis, HIV infection, etc). 7. Patients with low compliance for treatment according to the physician. 8. Pregnancy or breast-feeding patients. |
Country | Name | City | State |
---|---|---|---|
Israel | Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery | Haifa | North |
Lead Sponsor | Collaborator |
---|---|
Carmel Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | House-Brackmann scale | Time to complete recovery (Grade I- normal function) of facial palsy using the House-Brackmann scale for assessment. The scale is assessed by an ENT physician in four standard poses: at rest, with a forced smile, with raised eyebrows, and with eyes tightly closed and scored between I (normal function)- VI (complete palsy, worse outcome). | 14 days- 90 days | |
Secondary | Time to incomplete recovery | Time to presentation of House-Brackmann Grade II or worse and the difference between House-Brackmann scores between visits (i.e improvement from House-Brackmann 4 to 2) | 14 days- 90 days | |
Secondary | Occurrence of Motor Synkinesis | Occurrence of abnormal synchronization of facial movement where muscles, other than those intended, contract together during a particular movement pattern. | 14 days- 90 days | |
Secondary | Duration of neurological symptoms | Duration of hypoesthesia (trigeminal/ glossopharyngeal), periauricular pain, dysgusia, hyperacusis | 14 days- 90 days | |
Secondary | Duration of ocular symptoms | Duration of dryness, epiphora, itching, eye pain, etc | 14 days- 90 days | |
Secondary | Adverse effects of prednisone use | Incidence of dyspepsia, loss of blood sugar control, headache, fatigue, dizziness and insomnia, recurrent duodenal ulcers, mood swings, acute psychosis, etc | 14 days- 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05679752 -
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
|
N/A | |
Terminated |
NCT03996525 -
Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury
|
N/A | |
Enrolling by invitation |
NCT02179684 -
Surgery or Clincial Follow up, in Patients With Bell' s Palsy
|
N/A | |
Not yet recruiting |
NCT06063954 -
Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
|
N/A | |
Completed |
NCT04807491 -
Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy
|
N/A | |
Completed |
NCT03592797 -
Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis
|
N/A | |
Recruiting |
NCT03781700 -
Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
|
Phase 4 | |
Recruiting |
NCT06029855 -
Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
|
N/A | |
Recruiting |
NCT06459830 -
Mime Therapy With and Without Neural Mobilization in Bell's Palsy.
|
N/A | |
Recruiting |
NCT06340009 -
MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy
|
N/A | |
Completed |
NCT04280120 -
Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT05891106 -
AONDA Therapeutic Indication Study I
|
||
Completed |
NCT03974763 -
Function and Form Outcomes in Patients With Facial Paralysis
|
||
Active, not recruiting |
NCT05997199 -
The Effect Vitamin D on the Recovery Rate of Bell Palsy
|
||
Completed |
NCT04412733 -
EFFECTÄ°VENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
|
N/A | |
Recruiting |
NCT06028191 -
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
|
N/A | |
Recruiting |
NCT05582915 -
Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults
|
||
Terminated |
NCT03836989 -
Electrical Stimulation to Promote Recovery in Bells Palsy
|
N/A | |
Recruiting |
NCT05270187 -
Multiwave Locked System Laser for Patients With Bell's Palsy.
|
N/A | |
Recruiting |
NCT06308250 -
Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy
|
N/A |