Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention
NCT ID: NCT05846217
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2021-05-01
2023-04-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PBMT Group
In PBMT group, we choose 9 points on the affected face, include Mastoid, Preauricular, Temple, Frontalis muscle, Zygomatic muscle, Buccinator muscle, Masseter, Orbicularis oris and Depressor angulli oris. Based on clinical experience, we choose 7 acupoints, including LI4 (HeGu), LI11(QuChi), ST25 (TianShu), ST36 (ZuSanLi), SP6 (SanYinJiao), KI3 (TaiXi), LR3 (TaiChong). All the acupoint were applied bilaterally.
Laser divice directly contacts the points. All those points near the superficial roots of facial nerve. At each point, we treated for 1min, 1500 Hz, 50% laser intensity. And patients in PBMT group wore safety glasses to prevent eye damage during the laser sessions. All treatments were performed in the outpatient clinic by the same physician.
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.
Control Group
Patients in the control group received no intervention but were free to pursue therapies if desired.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Locations
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Beijing TongRen Hospital, Capital Medical University
Beijing, , China
Countries
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References
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Wu D, Lan X, Litscher G, Zhao YL, Wu YQ, Dai RJ, Cao K, Wang Y, Chen LQ. Laser acupuncture and photobiomodulation therapy in Bell's palsy with a duration of greater than 8 weeks: a randomized controlled trial. Lasers Med Sci. 2024 Jan 13;39(1):29. doi: 10.1007/s10103-023-03970-4.
Other Identifiers
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Laser-Bell-2023
Identifier Type: -
Identifier Source: org_study_id
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