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RecruitingNCT07519421

Different Laser Frequencies on Neuropathic Outcomes in Patients With Bell's Palsy

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Kafrelsheikh University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

this study was done to compare different laser frequencies on neuropathic outcomes in patients with Bell's palsy.

Detailed description

This study aims to compare the efficacy of different laser irradiation wavelengths (808 nm, 980 nm, and 1064 nm) in treating facial nerve lesions, which can lead to paralysis and impaired facial movement. The findings are expected to inform clinical decisions, enhance treatment outcomes, and improve rehabilitation protocols for patients with Bell's palsy, ultimately aiming to enhance their quality of life.

Conditions

Interventions

TypeNameDescription
DEVICEsham laser therapythe laser irradiation will be deactivated in the sham laser device by its manufacturer, but its visual light and acoustic functions maintained. The output power of the sham laser's infrared light will be zero mW, will be applied over the eight points over the face
DEVICELow-Level Laser TherapyLow-Level Laser Therapy (LLLT) for 5 min over eight points over the face, with the laser probe in direct contact with the superficial roots of the facial nerve. The parameters will be used wavelength of 830 nano meter, frequency of 1 kilohertz, the duty cycle of 80%, and energy density of 10 J/cm'. During each session, the total energy will be delivered to the patient are 80 Jole.
DEVICEgallium arsenide diode laser (BTL-5000 laser)gallium arsenide diode laser (BTL-5000 laser) will be used with infrared probes of 830 nm wavelength and 100 mW output power, average energy density of 10 J/em?, a frequency of 1 kilohertz, and a duty cycle of 80 %. In all cases, the laser will be in direct contact with the superficial roots of the facial nerve on the affected side and will be applied for 2 min and 5 s per point for 8 points with a total energy of 80 J
DEVICEhigh intensity laser treatmentHigh intensity laser therapy treatment with pulsed neodymium doped: yttrium aluminum garnet laser. The apparatus provided the following options: pulsed emission (1,064 nm), very high peak powers (3 kW), high levels of fluency (energy density) (810-1,780 mJ/cm), brief duration (120-150 Ms), low frequency (10-40 Hertz), and a duty cycle of approximately 0.1 %. High intensity laser therapy will be applied with contact and perpendicular to the superficial roots of the facial nerve of the affected side. The time of application will be 7 s/per point with an energy density of 10 J/em'. The total energy delivered to the patient during one session will be 80 joules. The device calculates the number of pulses, energy received for each session, and the total energy delivered to the patient during the treatment session
OTHERExercisesPatients in all treatment groups received massage to the facial muscles and facial exercises. The facial exercises may include different facial expressions in front of mirror, applying a resistance to the sound side to reinforce the weakened side. A resisted exercise to the neck muscles was performed in all direction to encourage the movement of the facial muscles as neuromuscular facilitation exercises for facial muscles

Timeline

Start date
2025-12-01
Primary completion
2026-05-01
Completion
2026-06-15
First posted
2026-04-09
Last updated
2026-04-09

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT07519421. Inclusion in this directory is not an endorsement.