Laser Acupuncture for Idiopathic Bell's Palsy

Capital Medical University

Status: Enrolling

Conditions: Bell Palsy

Treatments: Drug: Steroids; Device: Laser acupuncture; Device: Sham laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06732622

Laser-Bell-2025

Details and patient eligibility

About

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.

Full description

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, 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: 360 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. 2. 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: Double Blind

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360 participants in 3 patient groups

Laser acupuncture Group

Experimental group

Treatment:

Device: Laser acupuncture

Drug: Steroids

Sham laser acupuncture Group

Sham Comparator group

Treatment:

Device: Sham laser acupuncture

Drug: Steroids

Control group

Other group

Treatment:

Drug: Steroids