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Photobiomodulation Therapy for Facial Paralysis Over 8 Weeks: An Open-Label Pilot, Non-concurrent Control Study
Objective: Facial paralysis can be caused by a variety of etiological factors, complete palsy continues for two months, the chance of full recovery is reduced to zero. The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the in patients undergoing facial paralysis over 8 weeks. Methods: This study was an open-label, not concurrent control study including 54 patients that underwent facial paralysis over 8 weeks. Patients were assigned to the PBMT group and control group, with 27 patients in each group. Laser treatments were applied 3 days a week after recruited. PBMT was delivered using a class IV Multi-wave Locked System that combines with a simultaneous 808 nm continuous emission and 905 nm pulse emission and the maximum peak power was 25 W. 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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Beijing TongRen Hospital, Capital Medical University
Beijing, China
Start Date
January 1, 2021
Primary Completion Date
January 1, 2022
Completion Date
May 1, 2022
Last Updated
November 9, 2022
54
ACTUAL participants
MLS laser
DEVICE
Lead Sponsor
Beijing Tongren Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT06538103