Clinical trial
Photobiomodulation Therapy for Idiopathic Facial Paralysis: Nonrandomized Trial Controlled
Name
PBMT-IFP-2022
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. Without treatment, 30% of patients with complete paralysis will not completely recover. Therefore, shortening the recovery time will accelerate the recovery process leading to better results.
The objective of this study was to determine whether photobiomodulation therapy with laser acupuncture therapy could relieve symptoms in patients with Bell's palsy.
Methods:
This study was an open-label, randomized controlled trial including 96 patients that undergoing Bell's palsy. All the patients received oral vitamin B1.
Patients were assigned to the laser acupuncture (LA) group and control group, with 102 patients in each group. LA group were received 4 weeks of Laser treatment (3 times per week), while control group were received sham laser treatment.
Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.
Trial arms
Trial start
2021-01-01
Estimated PCD
2023-02-20
Trial end
2023-02-20
Status
Completed
Treatment
MLS laser
Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.
Arms:
Control Group, Laser acupuncture Group
Oral vitamin B1
Oral vitamin B1 10mg, times/day
Arms:
Control Group, Laser acupuncture Group
Size
96
Primary endpoint
The House-Brackmann Facial Nerve Grading System
Change from Baseline number of pathological HB grading at 4-weeks in post-therapy.
The Sunnybrook Facial Grading System
Change from Baseline scores of SB grading at at 4-weeks in post-therapy.
Eligibility criteria
Inclusion Criteria:
* (1) Clinical diagnosis of Bell's Palsy. (2) Adults over 18 years of age and under 60 years of age.
Exclusion Criteria:
- (1) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.
(2) Serious mental illness or social problems, and neurological disorders. (3) Planning for pregnancy, in pregnancy or lactation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}
Updated at
2023-11-24
1 organization
1 product
1 indication
Organization
Beijing Tongren HospitalProduct
Vitamin B1Indication
Bell's Palsy