Laser Acupuncture for Idiopathic Bell's Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laser acupuncture, Steroids, Sham laser acupuncture.
- Who it may be relevant to
- Registry conditions: Bell Palsy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Laser Acupuncture for Idiopathic Bell's Palsy: a Randomized Controlled Trial
Overview
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
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.
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 fo - 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 (
Primary outcome measures
- House Brackmann Grading System (HB) [Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24]
Secondary outcome measures (3)
- Sunnybrook Facial Grading Scale (SB Grading) [Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24]
- Facial Disability Index (FDI) [Time frame: Baseline, weeks 2, 4, 6, 8, 12 and 24]
- Facial Clinimetric Evaluation Scale (FaCE Scale) [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- China Beijing TongRen Hospital, Capital Medical University Beijing, China — Beijing
Identifiers
NCT: NCT06732622 · Laser-Bell-2025