Photobiomodulation Therapy for Idiopathic Facial Paralysis

• Status: Completed
• Trial end date: 2022-02-20
• Target enrollment: 0
• Participant gender: All

Summary

Objective:

Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. Without treatment, 30% of patients with complete paralysis will not completely recover. Therefore, shortening the recovery time will accelerate the recovery process leading to better results.

The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the patients undergoing Bell's palsy.

Methods:

This study was an open-label, randomized controlled trial including 96 patients that undergoing Bell's palsy.

Patients were assigned to the PBMT group and control group, with 48 patients in each group. PBMT group were received 12 sessions of PBMT (3 times per week), while control group were received prednisolone treatment.

Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tongren Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• (1) Adults over 18 years of age and under 60 years of age. (2) The patients were informed and signed the informed consent.

Exclusion Criteria:

• (1) Planning for pregnancy, in pregnancy or lactation. (2) Greater than 90% denervation on ENoG. (3) No voluntary EMG activity. (4) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.

(5) Serious mental illness or social problems, and neurological disorders. (6) Planning for pregnancy, in pregnancy or lactation.