Clinical trial
Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy: A Randomized Controlled Trial
Name
Laser-Bell-2024
Description
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.
Trial arms
Trial start
2022-03-01
Estimated PCD
2024-01-01
Trial end
2024-02-01
Status
Completed
Treatment
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.
Arms:
Laser acupuncture Group, Sham laser acupuncture Group
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.
Arms:
Control group, Laser acupuncture Group, Sham laser acupuncture Group
Size
336
Primary endpoint
House Brackmann Grading System (HB)
Baseline, weeks 2, 4, 6, 8, 12 and 24
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 336, 'type': 'ACTUAL'}}
Updated at
2024-03-29
1 organization
1 product
1 indication
Organization
Beijing Tongren HospitalProduct
SteroidsIndication
Bell's Palsy