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

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, 100μsec 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.