Multiwave Locked System Laser for Patients With Bell's Palsy.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Efficacy of Multiwave Locked System Laser on Recovery of Patients With Bell's Palsy: A Randomized Placebo Controlled Trial.

Conditions
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Facial Paralyses, Idiopathic, Laser Therapy, Bell Palsy

Intervention / Treatment
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* Other: Photobiomodulation therapy (laser therapy)
* Other: Facial massage and facial expression exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient who has unilateral IBP either on the right or left side. Treatment will begin in the sub-acute stage of illness 3-5 days after the acute onset subsided. patients will accept to attend to the physical therapy department to receive their corresponding treatment twice a week for successive six weeks. Exclusion Criteria: Patients who have central nervous system pathology sensory loss over the face, or recurrence of BP. Patients with upper motor facial nerve palsy will be also excluded. Any infant or child (≤18 years) with BP will be also excluded. Chronic facial palsy patients Patients BP having after a tumor, stroke, and Lyme disease will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 60 recruited patients will be randomly assigned into three groups of 20 patients in each. Group one will receive MLS laser therapy with 10 J/cm2 in scanning mode to the affected side plus facial massage and exercises. Group two will receive MLS laser therapy to predetermined eight motor points to facial muscles plus facial massage and exercises. Group three will receive placebo laser plus facial massage and exercises.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scanning Gorup<br>Patients in this group will receive facial massage, facial expression exercises and a Multiwave Locked System Laser with energy density 10 J/cm2. Laser will scan the affected side after calculating the distance and the total energy delivered to the one side of the face. The average treatment area is 50 cm2. The energy density was 10 J/cm2 with a total energy of 500 J and the treatment time is approximately 15 minutes. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles. | Other: Photobiomodulation therapy (laser therapy)<br>* 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.<br>* Other names: Multiwave Locked System Laser;Other: Facial massage and facial expression exercises<br>* 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.<br>* Other names: Exercises;|
| Experimental: Point laser Group<br>Patients in this group will received facial massage, facial expression exercises and laser at predetermined eight points on the affected side of the facial muscles. the hand piece is positioned perpendicular to 8 points which is located on the superficial roots of the facial nerve of the affected side. Each point will receive an energy density of 10 J/point with total energy delivered to the patient during one session of 80 joules. The time of application 90 sec/point. laser is calibrated by the manufacture company before the starting the experiment and periodically during the sessions. The laser probe will be away from the eye region. Both patients and therapist wear a laser googles. | Other: Photobiomodulation therapy (laser therapy)<br>* 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.<br>* Other names: Multiwave Locked System Laser;Other: Facial massage and facial expression exercises<br>* 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.<br>* Other names: Exercises;|
| Placebo Comparator: Control Group<br>patients in this group will receive only facial massage, facial expression exercises and placebo laser. Facial expression exercises include 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. | Other: Facial massage and facial expression exercises<br>* 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.<br>* Other names: Exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | The scores of the questionnaire will be collected after six weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | The scores of the questionnaire will be collected after six weeks after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bell's palsy, Multiwave locked system laser therapy, facial disability scale, House-Brackmann scale