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

NCT07519421 | Recruiting

• 1 other identifier: Ahmed-Msc
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathy, Facial; Bell Palsy; Laser

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline and after 6 weeks

Study Arms (4)

sham laser therapy

ACTIVE COMPARATOR

20 participants will receive a sham laser device, which will be applied over the eight points over the face. And will be applied for a total of 18 treatment sessions over a period of 6 consecutive weeks (three sessions/week).

Device: sham laser therapy; Other: Exercises

Low-Level Laser Therapy

EXPERIMENTAL

20 participants will receive Low-Level Laser Therapy (LLLT) for 5 min over eight points over the face for a total of 18 treatment sessions over a period of 6 consecutive weeks (three sessions/week)

Device: Low-Level Laser Therapy; Other: Exercises

gallium arsenide diode laser

EXPERIMENTAL

20 participants will receive gallium arsenide diode (GaAs) laser (BTL-5000 laser) for a total of 18 treatment sessions over a period of 6 consecutive weeks (three sessions/week)

Device: gallium arsenide diode laser (BTL-5000 laser)

high intensity laser treatment

ACTIVE COMPARATOR

20 participants will receive high-intensity laser treatment with a pulsed neodymium-doped yttrium aluminum garnet laser for a total of 18 treatment sessions over a period of 6 consecutive weeks (three sessions/week)

Device: high intensity laser treatment; Other: Exercises

Interventions

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

sham laser therapy

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.

Low-Level Laser Therapy

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

Low-Level Laser Therapy; high intensity laser treatment; sham laser therapy

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

gallium arsenide diode laser

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

high intensity laser treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

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

Madinah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Facial Nerve Diseases; Bell Palsy

Interventions

Low-Level Light Therapy; Exercise

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ahmed Eid Lafi Aljohani, physical therapist

CONTACT

00966564988366; pt.ahmad3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

SA (1)