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Photobiomodulation Therapy for Idiopathic Facial Paralysis

NCT05585346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-11-24

No results posted yet for this study

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 objective of this study was to determine whether photobiomodulation therapy with laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.

Methods:

This study was an open-label, randomized controlled trial including 96 patients that undergoing Bell's palsy. All the patients received oral vitamin B1.

Patients were assigned to the laser acupuncture (LA) group and control group, with 102 patients in each group. LA group were received 4 weeks of Laser treatment (3 times per week), while control group were received sham laser 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.

Conditions

  • Bell's Palsy

Interventions

DEVICE

MLS laser

Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.

DRUG

Oral vitamin B1

Oral vitamin B1 10mg, times/day

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-02-20
Completion
2023-02-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585346 on ClinicalTrials.gov