Bell Palsy, Facial Paralyses, Idiopathic, Laser Therapy
Conditions
Keywords
Bell's palsy, Multiwave locked system laser therapy, facial disability scale, House-Brackmann scale
Brief 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
Detailed 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.
Interventions
OTHERPhotobiomodulation therapy (laser therapy)
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.
OTHERFacial massage and facial expression exercises
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.
Sponsors
Umm Al-Qura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
By sealed envelopes, the allocation concealment will be achieved. Patient randomization is performed simply by computer number generator for each patient using GraphPad software. All eligible participants will be evaluated by independent physician and will be treated by the same therapist. The physician conducts the processes of participant enrollment, and allocation. The same assessors will measure the measured outcome. Both the therapist and the assessor will be blinded (masked) from patient's enrollment into the three study groups.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial disability scale (FDI) | The scores of the questionnaire will be collected at the baseline before treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| House-Brackmann scale (HBS) | The scores of the questionnaire will be collected at the baseline before starting of the treatment | 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. |
| House-Brackmann scale HBS | The scores of the questionnaire will be collected after three weeks after treatment. | 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. |
Countries
Saudi Arabia
Contacts
Primary ContactMohamed S Alayat, Ph.D
Outcome results
None listed