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, 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.

Selective Electrical Surface Stimulation to Support Functional Recovery in the Early Phase After Unilateral Acute Facial Nerve or Vocal Fold Paralysis

“…These observations are important when interpreting the published results and clinical protocols: Loyo et al, for example, published a protocol planning to use 100 μs pulses at 35 Hz stimulation rate in a prospective, double-blinded, randomized, placebo-controlled study investigating the effect of electrostimulation on recovery from acute Bell's palsy in patients with poor prognostic factors ( 54 ). We are concerned that this might not be effective, especially when applied to facial muscles of patients with poor prognosis, i.e.…”

Facial paralysis: timing of repair and management of the nonflaccidly paralyzed face

“…There is thought that electrical stimulation could reduce the sequelae of facial paralysis by preventing muscle atrophy and improving the selectivity of motor nerve regeneration; however, study results vary. Given the general poor study qualities with varied outcome measures on the use of electrical stimulation, a recent randomized control trial protocol was developed to evaluate the effects of high voltage electrical stimulation more conclusively, using pulsed electrical stimulation on Bell's palsy patients with a poor recovery prognosis [23]. Physical therapy has been shown to greatly improve facial function and QOL in patients who have already developed NFFP and has gained widespread acceptance as an initial treatment [24–26].…”

The Effectiveness of Electrical Stimulation For Bell's Palsy Patients: Literature Review

“…Therefore, the brain cannot command the facial muscles to move forward. However, there are several theories that are often put forward as the cause of Bell's palsy, namely the theory of vascular ischemia, the theory of viral infection, the theory of immunology, and the theory of heredity (Loyo et al, 2020). Electrical stimulation is a transcutaneous electrical stimulus that produces a low-amplitude pulsatile electric current that normally activates motor nerves that innervate weak muscles, produce contractions and prevent muscle atrophy.…”