Laser Acupuncture for Idiopathic Bell's Palsy

NCT06732622 | Recruiting

• 1 other identifier: Laser-Bell-2025
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bell Palsy

Keywords

Bell's Palsy; Laser acupuncture; Photobiomodulation; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sunnybrook Facial Grading Scale (SB Grading)

  Baseline, weeks 2, 4, 6, 8, 12 and 24

• Facial Disability Index (FDI)

  Baseline, weeks 2, 4, 6, 8, 12 and 24

• Facial Clinimetric Evaluation Scale (FaCE Scale)

  Baseline, weeks 2, 4, 6, 8, 12 and 24

Study Arms (3)

Laser acupuncture Group

EXPERIMENTAL

Device: Laser acupuncture; Drug: Steroids

Sham laser acupuncture Group

SHAM COMPARATOR

Drug: Steroids; Device: Sham laser acupuncture

Control group

OTHER

Drug: Steroids

Interventions

Laser acupuncture 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).

Laser acupuncture Group

Steroids 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.

Control group; Laser acupuncture Group; Sham laser acupuncture Group

Sham laser acupuncture 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).

Sham laser acupuncture Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Bell Palsy

Interventions

Steroids

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Dong Wu, Doctor

CONTACT

8613810988682; wudong0120@outlook.com

Haihong Lian, Doctor

CONTACT

8618811612190; lianhh123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CN (1)