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Recruiting NCT07519421

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

No phase Interventional Neuropathy, Facial Bell Palsy Laser

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sham laser therapy, Low-Level Laser Therapy, gallium arsenide diode laser (BTL-5000 laser), high intensity laser treatment.
Who it may be relevant to
Registry conditions: Neuropathy, Facial, Bell Palsy, Laser. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device sham laser therapy
    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
  • Device Low-Level Laser Therapy
    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.
  • Device gallium 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
  • Device high intensity laser treatment
    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 si
  • Other Exercises
    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

Primary outcome measures

  • assessment of Compound motor action potential of facial nerve [Time frame: at baseline and after 6 weeks]

Eligibility criteria

Inclusion criteria

  • 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.
  • Patients will on level II, III, IV and V of House-Brackmann scale.

Exclusion criteria

  • 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
  • Severe hypertension (Blood pressure more than 200/120 mmHg).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • outpatient clinic, Department of physical therapy at King Fahd Hospital in Almadinah Almun — Madinah

Identifiers

NCT: NCT07519421 · Ahmed-Msc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗