Clinical trial NCT05585333: Photobiomodulation Therapy Treatment on Facial Paralysis
Official title: Photobiomodulation Therapy for Facial Paralysis Over 8 Weeks: An Open-Label Pilot, Non-concurrent Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Paralysis
Keywords: Facial paralysis
photobiomodulation
ENoG
EMG
HB grading
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Facial paralysis can be caused by a variety of etiological factors, complete palsy continues for two months, the chance of full recovery is reduced to zero. The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the in patients undergoing facial paralysis over 8 weeks.

Methods: This study was an open-label, not concurrent control study including 54 patients that underwent facial paralysis over 8 weeks. Patients were assigned to the PBMT group and control group, with 27 patients in each group. Laser treatments were applied 3 days a week after recruited. PBMT was delivered using a class IV Multi-wave Locked System that combines with a simultaneous 808 nm continuous emission and 905 nm pulse emission and the maximum peak power was 25 W. 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) adults over 18 years of age and under 65 years of age. (2) had not received medicine, such as prednisolone. (3) had history of Bell's palsy, Ramsay Hunt syndrome, traumatic facial paralysis and history of otological surgery.

(4) Disease duration longer than two months.

Exclusion Criteria:

- (1) Complete facial paralysis (HB 6). (2) Greater than 90% denervation on ENoG. (3) No voluntary EMG activity. (4) No latency of early (R1) and late (R2, R2') components in blink reflex. (5) Serious mental illness or social problems, and neurological disorders. (6) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.

(7) 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 6-months in post-therapy.
measure: The Sunnybrook Facial Grading System
timeFrame: Change from Baseline scores of SB grading at at 6-months in post-therapy.
measure: Facial Clinimetric Evaluation Scale
timeFrame: Change from Baseline scores of FaCE at at 6-months 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 6-months in post-therapy.
measure: Electromyography (EMG)
timeFrame: Change from Baseline amplitude and duration of MUAPs at at 6-months 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: