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Protocol for randomized controlled trial of electric stimulation with high-volt twin peak versus placebo for facial functional recovery from acute Bell’s palsy in patients with poor prognostic factors

ABSTRACT:

Background

Electric stimulation (ES) can prevent muscle atrophy and promote tissue healing and therefore may help prevent sequelae of Bell’s palsy but due to lack of high-quality studies, the effectiveness of ES in Bell’s palsy remains controversial. Here we describe a protocol to evaluate the effects of monophasic high volt ES in patients with Bell’s palsy and poor prognosis for recovery.

Results

This is a protocol for a prospective, double-blinded, randomized, placebo-controlled study. Participants include adults with acute Bell’s palsy with poor prognosis for full recovery due to complete paralysis or being over age 60. ES will be a monophasic, high-volt pulsed waveform, 100?sec pulse duration, 35?hertz, motor-level intensity. Follow up will be at months 1, 2, 3 and 6. The primary outcome will be the proportion of patients with complete recovery using the eFACES tool. Secondary outcomes include patient reported quality of life measured by FaCE and the synkinesis assessment questionnaires, objective photographs, time to complete recovery, adverse effects, and tolerability.

Conclusion

This protocol has the potential to provide high quality evidence regarding the effects, up to 6?months after onset, of pulsed monophasic high-volt ES for patients with acute Bell’s palsy and poor prognosis for complete recovery.

SUBMITTER: Loyo M

PROVIDER: S-EPMC7734495 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThe aim of this study was to report the incidence and clinical course of a series of patients who were misdiagnosed with Bell's palsy and were eventually proven to have occult neoplasms.MethodsTwo hundred forty patients with unilateral facial paralysis who were assessed at the facial nerve reanimation clinic, Victoria Hospital, London Health Science Centre, from 2008 through 2017 were reviewed. Persistent paralysis without recovery was the presenting complaint.ResultsNine patients (3.8%) who were proven to have occult neoplasms initially presented with a diagnosis of Bell's palsy. The mean diagnostic delay was 43.5 months. Four patients were proven to have skin cancers, 3 patients had parotid cancers, and 2 patients had facial nerve schwannomas as a final diagnosis. Initial magnetic resonance imaging (MRI) was performed in all 9 patients and 8 underwent a follow-up MRI. An occult tumor was identified upon review of the original MRI in one patient and at follow-up MRI in 8 patients. The mean time interval between the initial and follow-up imaging was 30.8 months. The disease status at most recent follow-up were no evidence of disease in 2 patients (22%) and alive with disease in 7 patients (78%). An irreversible, progressive pattern of facial paralysis combined with pain, multiple cranial neuropathies or history of skin cancer were predictable risk factors for occult tumors. Seven out of the 9 patients (77.8%) underwent at least one type of facial reanimation surgery, and the final subjective results by the surgeon were available for 5 patients. Three out of the 5 (60%) patients who were available for final subjective analysis were reported as Grade III according to the modified House-Brackmann scale.ConclusionOccult facial nerve neoplasm should be suspected in patients with progressive and irreversible facial paralysis but the diagnosis may only become evident with follow-up imaging. Facial reanimation surgery is a satisfactory option for these patients.