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.

Study Overview

• Status: Completed
• Conditions: Bell Palsy; Laser; Neuropathy, Facial
• Intervention / Treatment: Device: sham laser therapy; Other: Exercises; Device: Low-Level Laser Therapy; Device: gallium arsenide diode laser (BTL-5000 laser); Device: high intensity laser treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Madinah, Saudi Arabia
    • outpatient clinic, Department of physical therapy at King Fahd Hospital in Almadinah Almunawwarah.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Eighty subjects from both genders diagnosed with Bell's palsy will be recruited through direct referrals from their independent physician's neurology department.
2. Subjects aged 18 and above from all genders
3. Unilateral Bell's palsy either on the right or left side.
4. The Facial disability index will be used for assessment and progression of Bell's palsy before and after treatment protocol.
5. Patients will on level II, III, IV and V of House-Brackmann scale.

Exclusion Criteria:

1. We will exclude patients who had central nervous system pathology, sensory loss over the face, or recurrence of facial palsy.
2. Upper motor neuron fascial nerve palsy.
3. Any infant or child (<18 years).
4. Bilateral Facial nerve palsy
5. Severe hypertension (Blood pressure more than 200/120 mmHg).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sham laser therapy; 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; 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; Other: Exercises; Patients in all treatment groups received the same standardized rehabilitation programme consisting of facial massage, mirror exercises, and resisted facial and neck exercise
Experimental: Low-Level Laser Therapy; 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)	Other: Exercises; Patients in all treatment groups received the same standardized rehabilitation programme consisting of facial massage, mirror exercises, and resisted facial and neck exercise; 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 808 nm (Polaris HP, Astar, Bielsko-Biała, Poland) and 980 nm (TheraLASER max, TheraMarkt, Germany), 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 1440 J per session (8 treatment points × 180 J per point; 3 W average power over a 6 cm² applicator, 60 s per point).
Experimental: gallium arsenide diode laser; 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); 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 1440 J per session (8 treatment points × 180 J per point; 3 W average power over a 6 cm² applicator, 60 s per point)
Active Comparator: high intensity laser treatment; 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)	Other: Exercises; Patients in all treatment groups received the same standardized rehabilitation programme consisting of facial massage, mirror exercises, and resisted facial and neck exercise; 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 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 1440 J per session (8 treatment points × 180 J per point; 3 W average power over a 6 cm² applicator, 60 s per point). The device calculates the number of pulses, energy received for each session, and the total energy delivered to the patient during the treatment session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Facial-nerve distal latency and CMAP amplitude at the nasalis.	at baseline and after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary Outcome	Facial Disability Index - Physical subscale; Facial Disability Index - Social subscale	Both at baseline and at 6 weeks.

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): June 15, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cranial Nerve Diseases; Bell Palsy; Facial Nerve Diseases; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Laser Therapy; Phototherapy; Exercise; Low-Level Light Therapy
• Other Study ID Numbers: Ahmed-Msc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No