Laser Acupuncture for Idiopathic Bell's Palsy

NARecruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

May 1, 2026

Study Completion Date

June 1, 2026

Conditions
Bell Palsy
Interventions
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 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)."

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 12 days.

DEVICE

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)."

Trial Locations (1)

100730

RECRUITING

China Beijing TongRen Hospital, Capital Medical University Beijing, China, Beijing

All Listed Sponsors
lead

Beijing Tongren Hospital

OTHER