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Clinical Trial Summary

Background: Idiopathic Bell's palsy (IBP) is a unilateral facial paralysis of sudden onset and unknown etiology. Patient with IBP has an impaired facial expressions and psychological affection, which interfere with social communication. Multiwave locked system (MLS) laser therapy is a class IV laser with synchronizes emission of an 808 nm continuous laser and a 905 nm pulsed laser. It is proposed that MLS facilitates greater penetration and therapeutic effects than low-level laser therapy (LLLT). Aims: The aim of present study is to investigate the effect of MLS laser in the treatment of patients with unilateral IBP. Participant: A total number of 60 patients with IBP will be recruited from Makkah hospitals. Treatment will begin in the subacute phase as they referred from neuro-doctors. All the recruited patients will be randomly assigned into three groups of 20 patients each. Intervention: All patients will be treated with facial massage and exercises. In addition, group one will receive MLS laser with 10 J/cm2 in scanning mode while the group two will receive 10J/point for eight points. Measured variables: Facial disability scale (FDI) and House-Brackmann scale HBS will used to assess the grade of facial nerve recovery. The scores of both questionnaires will be collected at the baseline, after three and six weeks after treatment. Statistical Analysis: The Friedman and Wilcoxon signed ranks tests will be used to compare the FDI and HBS scores within each group


Clinical Trial Description

Multi-wave locked system (MLS) laser therapy had been presented in the arena of rehabilitation and attained interests of numerous researchers due to its unique features. MLS laser is a Class IV, high-power laser, which is characterized by a combination of two waveforms of continuous emissions of an 808 nm wavelength and a pulsed 905 nm emitted in synchrony. MLS used recently in research and revealed significant reduction of musculoskeletal pain and disability. Researchers recommend its use in case of muscle lesions and/or diseases. No proved way was shown to use laser in the treatment of facial palsy in either scanning the affected side or applying laser to specific motor points. It was proposed that the combination of the dual laser waveforms offers better penetrability and outcomes on than ordinary lasers and help in recovery of facial muscle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05270187
Study type Interventional
Source Umm Al-Qura University
Contact Mohamed S Alayat, Ph.D
Phone +966566003665
Email mohsalahpt@hotmail.com
Status Recruiting
Phase N/A
Start date January 10, 2022
Completion date April 2022

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