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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
The Multiwave Locked System Laser will treat both the scan and point application groups. M6 laser equipment (ASA, Arcugnano, Italy) is used in this study in the physiotherapy and rehabilitation department, Faculty of Applied Medical Science, Umm Al-Qura University. It provides synchronized and overlapping continuous and pulsed emissions of Ga-Al-Ar laser emitted in a single hand piece. M6 has a continuous emission of a wavelength of 808 nm with peak power of 1000 mW, mean power of 500mW, spot diameter of 2 cm, and spot area of 3.14 cm2. Pulsed emission has a wavelength of 905 nm, peak power of 25 W, and mean power of 54mW with frequency of 1500 Hz.
Facial massage and facial expression exercises will be applied for all patients in the three treatment groups. It includes simple facial expression exercises, active graduated strengthening exercises in front of a mirror (active assisted, freedom, and resisted), proprioceptive neuromuscular facilitation exercises for facial muscles, and resisted exercises for neck muscles. Participants are taught to perform massage and exercises correctly by the physiotherapist. All treatment groups are given instruction to repeat the massage and exercises two times a day for at least 6 weeks. The patient or one of his/her family members will confirm that the participant carries out the massage and exercises at home.
Umm Al-Qura University, Faculty of Applied Medical Science
Mecca, Saudi Arabia
RECRUITINGFacial disability scale (FDI)
The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.
Time frame: The scores of the questionnaire will be collected at the baseline before treatment.
Facial disability scale (FDI)
The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.
Time frame: The scores of the questionnaire will be collected after three weeks after treatment.
Facial disability scale (FDI)
The FDI was produced by Van Swearingen and Brach to improve the assessment of facial neuromuscular dysfunction. Beyond the impairment domain, this index provides a reliable measurement with construct validity for evaluating patients with facial nerve disorders.
Time frame: The scores of the questionnaire will be collected after six weeks after treatment.
House-Brackmann scale (HBS)
This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face \[6\]. It consists of six divisions (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) with grade one indicating a normal facial function in all areas and grade six indicating total paralysis.
Time frame: The scores of the questionnaire will be collected at the baseline before starting of the treatment
House-Brackmann scale HBS
This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face \[6\]. It consists of six divisions (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) with grade one indicating a normal facial function in all areas and grade six indicating total paralysis.
Time frame: The scores of the questionnaire will be collected after three weeks after treatment.
House-Brackmann scale HBS
This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face \[6\]. It consists of six divisions (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) with grade one indicating a normal facial function in all areas and grade six indicating total paralysis.
Time frame: The scores of the questionnaire will be collected after six weeks after treatment.
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