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NCT Number: NCT07519421

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

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

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Key information

Conditions

Neuropathy, Facial Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Infections LASER Mouth Diseases Nervous System Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

outpatient clinic, Department of physical therapy at King Fahd Hospital in Almadinah Almunawwarah.

Madinah, Saudi Arabia

Location status: Recruiting

Location contact

Ahmed Eid Lafi Aljohani, physical therapist

CONTACT

[email protected]

00966564988366

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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 outcomes

  1. assessment of Compound motor action potential of facial nerve

    Time frame: at baseline and after 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Eid Lafi Aljohani, physical therapist

CONTACT

[email protected]

00966564988366

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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