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Laser Acupuncture for Idiopathic Bell's Palsy

NCT ID: NCT06732622

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Bell Palsy

Keywords

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Bell's Palsy Laser acupuncture Photobiomodulation RCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Laser acupuncture Group

Group Type EXPERIMENTAL

Laser acupuncture

Intervention Type DEVICE

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 Sri, Vicenza, Italy).

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.

Acupoints:

we chose 5 acupoints on the affected side. This includes ST2 (Si Bai), ST4 (Di Cang), ST6 (Jia Che), GB14 (Yang Bai), GB20 (Feng chi). We choose 6 acupoints bilaterally, including LI4 (He Gu), LI11 (Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), and LR3 (Tai Chong).

Steroids

Intervention Type DRUG

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 12 days.

Sham laser acupuncture Group

Group Type SHAM_COMPARATOR

Steroids

Intervention Type DRUG

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 12 days.

Sham laser acupuncture

Intervention Type DEVICE

Patients in the laser acupuncture group (Sham 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 Sri, Vicenza, Italy).

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.

Acupoints:

we chose 5 acupoints on the affected side. This includes ST2 (Si Bai), ST4 (Di Cang), ST6 (Jia Che), GB14 (Yang Bai), GB20 (Feng chi). We choose 6 acupoints bilaterally, including LI4 (He Gu), LI11 (Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), and LR3 (Tai Chong).

Control group

Group Type OTHER

Steroids

Intervention Type DRUG

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 12 days.

Interventions

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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 Sri, Vicenza, Italy).

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.

Acupoints:

we chose 5 acupoints on the affected side. This includes ST2 (Si Bai), ST4 (Di Cang), ST6 (Jia Che), GB14 (Yang Bai), GB20 (Feng chi). We choose 6 acupoints bilaterally, including LI4 (He Gu), LI11 (Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), and LR3 (Tai Chong).

Intervention Type DEVICE

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 12 days.

Intervention Type DRUG

Sham laser acupuncture

Patients in the laser acupuncture group (Sham 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 Sri, Vicenza, Italy).

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.

Acupoints:

we chose 5 acupoints on the affected side. This includes ST2 (Si Bai), ST4 (Di Cang), ST6 (Jia Che), GB14 (Yang Bai), GB20 (Feng chi). We choose 6 acupoints bilaterally, including LI4 (He Gu), LI11 (Qu Chi), ST36 (Zu San Li), SP6 (San Yin Jiao), KI3 (Tai Xi), and LR3 (Tai Chong).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Wu, Doctor

Role: CONTACT

Phone: 8613810988682

Email: [email protected]

Haihong Lian, Doctor

Role: CONTACT

Phone: 8618811612190

Email: [email protected]

Facility Contacts

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Dong Wu, Doctor

Role: primary

Other Identifiers

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Laser-Bell-2025

Identifier Type: -

Identifier Source: org_study_id