Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy

Capital Medical University

Status

Enrolling

Conditions

Bell's Palsy

Treatments

Drug: Steroids

Device: Laser acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT06280794

Laser-Bell-2024

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. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.

Methods:

This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Prednisolone. Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).

Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24.

Enrollment

336 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.

Exclusion criteria

1.Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.

Planning for pregnancy, those in pregnancy, or those who were lactating. 3.Bell's Palsy patients who have a disease course of more than 8 weeks.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

336 participants in 3 patient groups

Laser acupuncture Group

Experimental group

Description:

Steroids. Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). Laser acupuncture used have wavelength of 808 nm and 905nm, 1.2 W power (808nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, administered for 3 times per week in the first 2 weeks, and 1500 Hz, 50% power level, 50% duty cycle, 8.35 J/cm2 dosimetry, 26.22 J for each point, in the last 2 weeks, 12 times total treatment.

Treatment:

Device: Laser acupuncture

Drug: Steroids

Sham laser acupuncture Group

Sham Comparator group

Description:

Steroids. Patients in the laser acupuncture group (LA group) received 12 sessions of laser acupuncture (3 times per week). Laser aucpuncture used a class IV Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy). In LA group, 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 6 acupoints, including LI4 (He Gu), LI11(Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), LR3 (Tai Chong). The Sham LA group received the same laser device and the same acupoints. The device showed the same red light but did not emit a laser, administered for 3 times per week in the 4 weeks.

Treatment:

Device: Laser acupuncture

Drug: Steroids

Control group

Other group

Description:

Steroids.

Treatment:

Drug: Steroids