Clinical trial NCT05846217: Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention
Official title: Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Treatment Relieve Symptoms of Chronic Bell's Palsy
Keywords: Bell'palsy
photobiomodulation
RCT
ENoG
EMG
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 84
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: To determine whether photobiomodulation therapy by class IV Multiwave Locked System laser treatment could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks.

METHODS AND METHODS: This randomized controlled trial from May 2021 to April 2023. Patients were eligible who had Bell's palsy with a duration of greater than 8 weeks on out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The photobiomodulation group received class IV Multiwave Locked System laser treatment for 3 times per weeks, a total of 6 months. The control group received the same Multiwave Locked System treatment procedure except the laser parameter. The primary outcome measures comprised House-Brackmann facial nerve grading system, Sunnybrook facial grading system, Facial Clinimetric Evaluation Scale. Secondary outcome measures comprised Electroneurography, Electromyography, and the Blink Reflex.


Eligibility criteria: Inclusion Criteria:

* Patients were eligible for House-Brackmann grading system (HB) greater than or equal to grade 3.
* Patients were adults over 18 years of age and under 60 years of age;
* Patients were not received medicine before 2 weeks of trial, such as prednisolone.

Exclusion Criteria:

* Patients were excluded HB grade 6, or greater than 90% denervation on electroneuronography, or no voluntary electromyography activity, or no latency of early (R1) and late (R2, R2') components in Blink Reflex patients.
* Patients were excluded serious mental illness or social problems, and neurological disorders. And systemic disease, such as severe diabetes, malignant tumors, and other serious consumptive diseases, planning for pregnancy, in pregnancy or lactation.

Primary outcomes:
measure: House-Brackmann grading system
timeFrame: Change from Baseline number of pathological HB grading at 6-months in post-therapy.
measure: electroneuronography
timeFrame: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6-months in post-therapy.]
Secondary outcomes:
measure: Sunnybrook Facial Grading Scale
timeFrame: Change from Baseline number of pathological SB grading at 6-months in post-therapy.
measure: electromyography
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: