Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy

Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy: A Randomized Controlled Trial

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 Betahistine Mesylate tablet, Vitamin B1 tablet and 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.

Study Overview

• Status: Completed
• Conditions: Bell's Palsy
• Intervention / Treatment: Device: Laser acupuncture; Drug: Steroids

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser acupuncture Group; 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.	Device: Laser acupuncture; 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.; Drug: Steroids; Prednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3 days; 10 mg daily for the after 3 days; 5 mg daily for the final 3 days, with a total treatment time of 9 days.
Other: Control group; Steroids.	Drug: Steroids; Prednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3 days; 10 mg daily for the after 3 days; 5 mg daily for the final 3 days, with a total treatment time of 9 days.
Sham Comparator: Sham laser acupuncture Group; 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.	Device: Laser acupuncture; 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.; Drug: Steroids; Prednisolone as 5 mg tablets (Tianjin Lisheng Pharmaceutical Co., Ltd., China) were given as a single dose of 30 mg daily for the first 3 days; 15 mg daily for the following 3 days; 10 mg daily for the after 3 days; 5 mg daily for the final 3 days, with a total treatment time of 9 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
House Brackmann Grading System (HB)	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.	Baseline, weeks 2, 4, 6, 8, 12 and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sunnybrook Facial Grading Scale (SB Grading)	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).	Baseline, weeks 2, 4, 6, 8, 12 and 24
Facial Disability Index (FDI)	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).	Baseline, weeks 2, 4, 6, 8, 12 and 24
Facial Clinimetric Evaluation Scale (FaCE Scale)	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).	Baseline, weeks 2, 4, 6, 8, 12 and 24

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: RCT; photobiomodulation; Laser acupuncture; Bell's palsy; Idiopathic facial paralysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: Laser-Bell-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No