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

Phase

N/A

Condition

Cataplexy

Treatment

N/A

Clinical Study ID

NCT05270187

22-MED-10023150

Ages > 18
All Genders

Study 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

Eligibility Criteria

Inclusion

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 onsetsubsided.
patients will accept to attend to the physical therapy department to receive theircorresponding treatment twice a week for successive six weeks.

Exclusion

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.

Study Design

January 10, 2022

April 30, 2022

Study 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.

Connect with a study center

Umm Al-Qura University, Faculty of Applied Medical Science
Mecca, 21955
Saudi Arabia
Active - Recruiting

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