RecruitingNot ApplicableNCT06732622

Laser Acupuncture for Idiopathic Bell's Palsy

Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial


Sponsor

Beijing Tongren Hospital

Enrollment

360 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

  • \. Patients diagnosed with idiopathic Bell's Palsy 2.Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.

Exclusion Criteria1

  • \. 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.

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Interventions

DEVICELaser 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).

DRUGSteroids

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.

DEVICESham 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).


Locations(1)

China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, China

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NCT06732622


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