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

ConditionsNeuropathy, Facial Bell Palsy Laser

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKafrelsheikh University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eighty subjects from both genders diagnosed with Bell's palsy will be recruited through direct referrals from their independent physician's neurology department.

Subjects aged 18 and above from all genders

Unilateral Bell's palsy either on the right or left side.

The Facial disability index will be used for assessment and progression of Bell's palsy before and after treatment protocol.

Disqualifiers

We will exclude patients who had central nervous system pathology, sensory loss over the face, or recurrence of facial palsy.

Upper motor neuron fascial nerve palsy.

Any infant or child (<18 years).

Bilateral Facial nerve palsy

Trial design

Design model

Parallel

Treatments tested in this trial

sham laser therapy
Device
the 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
Low-Level Laser Therapy
Device
Low-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.
gallium arsenide diode laser (BTL-5000 laser)
Device
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
high intensity laser treatment
Device
High 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
Exercises
Other intervention
Patients 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

Treatment groups

80 Participants

are divided into 4 treatment groups

Group A: sham laser therapyActive comparator 2 interventions

Group B: Low-Level Laser TherapyExperimental treatment 2 interventions

Group C: gallium arsenide diode laserExperimental treatment 1 intervention

Group D: high intensity laser treatmentActive comparator 2 interventions

Trial outcomes

Primary outcomes

assessment of Compound motor action potential of facial nerve

Compound motor action potential of the facial nerve was evaluated using electroneurography. This involved measuring latency and amplitude differences between the affected and non-affected sides of the nasalis muscle. Latency was calculated from the baseline to the initial deflection, while amplitude was determined as peak-to-peak measurements, with both measures yielding side-to-side differences. Degeneration percentage was calculated based on the amplitude comparison between sides, investigating the non-affected side first to find the optimal stimulation site, which was then mirrored on the affected side to ensure equal distance between the stimulating cathode and recording electrode on both sides.

Time frame

at baseline and after 6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

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