Laser Acupuncture for Idiopathic Bell's Palsy

Not Applicable

Recruiting

• Conditions: Bell Palsy
• Interventions: Device: Laser acupuncture; Drug: Steroids; Device: Sham laser acupuncture

• Registration Number: NCT06732622
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-05-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser acupuncture Group	Laser acupuncture	-
Laser acupuncture Group	Steroids	-
Sham laser acupuncture Group	Steroids	-
Sham laser acupuncture Group	Sham laser acupuncture	-
Control group	Steroids	-

Primary Outcome Measures

Name	Time	Method
House Brackmann Grading System (HB)	Baseline, weeks 2, 4, 6, 8, 12 and 24	The HB is a physician-rated system based on criteria of resting appearance, facial movements, and synkinesis that categorizes facial function from I (normal) to VI (total paralysis), with options of "Normal", "Mild dysfunction", "Moderate dysfunction", "Moderately severe dysfunction", "Severe dysfunction" or "Total paralysis". The prognoses of grade 3 or higher were abnormal.

Secondary Outcome Measures

Name	Time	Method
Sunnybrook Facial Grading Scale (SB Grading)	Baseline, weeks 2, 4, 6, 8, 12 and 24	The Sunnybrook Facial Grading Scale was used because of its international recognition and because it allowed a separate classification of the degree of synkinesis. The SB Grading is divided into three subscales of resting symmetry (Eye and Mouth range from 0 to 1, Cheek ranges from 0 to 2), symmetry of voluntary movement (ranges from 1 to 5), and synkinesis (ranges from 0 to 3). The three subscores are used to calculate a composite score (ranges from 0 to 100).
Facial Disability Index (FDI)	Baseline, weeks 2, 4, 6, 8, 12 and 24	Facial Disability Index (FDI) is a brief, self-report questionnaire of physical disability and psychosocial factors related to facial neuromuscular function. The FDI is a 10-item test that is divided into physical function (ranges from 0 to 5). and social/ well-being function (ranges from 1 to 6) domains. The physical function scores range from -25 (worst) to 100 (best), and the social/wellbeing function scores range from 0 (worst) to 100 (best).
Facial Clinimetric Evaluation Scale (FaCE Scale)	Baseline, weeks 2, 4, 6, 8, 12 and 24	FaCE is 15-items, self-reported questionnaire that used to assess facial impairment and disability after facial paralysis.; It includes six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. the total scores range from 0 (worst) to 100 (best).

Trial Locations

Locations (1)

China Beijing TongRen Hospital, Capital Medical University Beijing, China; 🇨🇳 Beijing, Beijing, China