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Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention

NCT05846217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Laser Treatment Relieve Symptoms of Chronic Bell's Palsy

Interventions

DEVICE

Multiwave Locked System

Multiwave Locked System laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-02-28
Completion
2023-04-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846217 on ClinicalTrials.gov