Clinical trial NCT05585346: Photobiomodulation Therapy for Idiopathic Facial Paralysis
Official title: Photobiomodulation Therapy for Idiopathic Facial Paralysis: Nonrandomized Trial Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell's Palsy
Keywords: Idiopathic facial paralysis
Bell's palsy
photobiomodulation
RCT
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: The House-Brackmann Facial Nerve Grading System
timeFrame: Change from Baseline number of pathological HB grading at 4-weeks in post-therapy.
measure: The Sunnybrook Facial Grading System
timeFrame: Change from Baseline scores of SB grading at at 4-weeks in post-therapy.
Secondary outcomes:
measure: Electroneuronography (ENoG)
timeFrame: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 4-weeks in post-therapy.
measure: Electromyography (EMG)
timeFrame: Change from Baseline amplitude and duration of MUAPs at at 4-weeks in post-therapy.
measure: Blink Reflex
timeFrame: Change from Baseline number of pathological Blink Reflex at 6-months in post-therapy.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TongRen Hospital, Capital Medical University
Study officials:
References: