Photobiomodulation Therapy for Idiopathic Facial Paralysis

Capital Medical University

Status

Completed

Conditions

Bell's Palsy

Treatments

Drug: Oral vitamin B1

Device: MLS laser

Study type

Interventional

Funder types

Other

Identifiers

NCT05585346

PBMT-IFP-2022

Details and patient eligibility

About

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Laser acupuncture Group

Experimental group

Description:

LA group used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz. In LA group, based on clinical experience, we choose 5 acupoints on the affected side. It includes ST2(Si Bai), ST4(Di Cang), ST6(Jia Che), GB14(Yang Bai), GB20(Feng chi). We choose 7 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST25 (Tian Shu), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The acupoints in the limbs and trunk area, were applied bilaterally. Power of laser device is 50%. Oral vitamin B1.

Treatment:

Drug: Oral vitamin B1

Device: MLS laser

Control Group

Active Comparator group

Description:

LA group used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). MLS laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz. In LA group, based on clinical experience, we choose 5 acupoints on the affected side. It includes ST2(Si Bai), ST4(Di Cang), ST6(Jia Che), GB14(Yang Bai), GB20(Feng chi). We choose 7 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST25 (Tian Shu), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The acupoints in the limbs and trunk area, were applied bilaterally. Power of laser device is 25%. Oral vitamin B1.

Treatment:

Drug: Oral vitamin B1

Device: MLS laser

Trial contacts and locations

1

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