NCT05585346

Photobiomodulation Therapy for Idiopathic Facial Paralysis

Completed NA Last updated 24 November 2023

What this trial tests

NA trial testing MLS laser in Bell's Palsy in 96 participants. Completed in 20 February 2023.

Timeline

1 January 2021

Primary endpoint
20 February 2023

20 February 2023

Quick facts

Lead sponsor	Beijing Tongren Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	1 January 2021
Primary completion	20 February 2023
Estimated completion	20 February 2023
Sites	1 location across China

Drugs / interventions tested

• MLS laser
• Oral vitamin B1

Conditions studied

• Bell's Palsy — all drugs for Bell's Palsy →

Sponsor

Beijing Tongren Hospital

Who can join

Adults 18 to 60, any sex, with Bell's Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.