Neuropathy, FacialNCT07519421
Different Laser Frequencies on Neuropathic Outcomes in Patients With Bell's Palsy
A study testing Low-Level Laser Therapy, gallium arsenide diode laser (BTL-5000 laser) and high intensity laser treatment in people with Neuropathy, Facial and Bell Palsy, run by Kafrelsheikh University at 1 site in Saudi Arabia.
Trial summary
this study was done to compare different laser frequencies on neuropathic outcomes in patients with Bell's palsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Facial, Bell Palsy, Laser
- What is being tested?
- Low-Level Laser Therapy, gallium arsenide diode laser (BTL-5000 laser) and high intensity laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
outpatient clinic, Department of physical therapy at King Fahd Hospital in Almadinah Almunawwarah.
Madinah
About this study
this study was done to compare different laser frequencies on neuropathic outcomes in patients with Bell's palsy.
Read the 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.
- Conditions
- Neuropathy, Facial, Bell Palsy, Laser
- Being tested
- sham laser therapy, Low-Level Laser Therapy, gallium arsenide diode laser (BTL-5000 laser), high intensity laser treatment, Exercises
- Medical subject headings
- Facial Nerve Diseases, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham laser therapyDevice
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 TherapyDevice
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).
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 1440 J per session (8 treatment points × 180 J per point; 3 W average power over a 6 cm² applicator, 60 s per point)
high intensity laser treatmentDevice
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
ExercisesOther
Patients in all treatment groups received the same standardized rehabilitation programme consisting of facial massage, mirror exercises, and resisted facial and neck exercise
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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) Receives: 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) Receives: Device: high intensity laser treatment; Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and after 6 weeks
Secondary outcomes (1)
secondary Outcome
Facial Disability Index - Physical subscale; Facial Disability Index - Social subscale
Measured: Both at baseline and at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Dec 2025
- Primary completion1 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy, FacialStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Eid Lafi Aljohani, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519421
- Sponsor's protocol ID
- Ahmed-Msc
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Laser Frequencies on Neuropathic Outcomes in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT07519421
- Acronym / sponsor ID
- Ahmed-Msc
- Conditions
- Neuropathy, Facial, Bell Palsy, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sham laser therapy | Active comparator | Device: sham laser therapy, Other: Exercises20 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). |
| Low-Level Laser Therapy | Experimental | Device: Low-Level Laser Therapy, Other: Exercises20 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) |
| gallium arsenide diode laser | Experimental | Device: gallium arsenide diode laser (BTL-5000 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) |
| high intensity laser treatment | Active comparator | Device: high intensity laser treatment, Other: Exercises20 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham laser therapythe 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 | sham laser therapy |
| Low-Level Laser TherapyLow-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). | Device | Low-Level Laser Therapy |
| 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) | Device | gallium arsenide diode laser |
| high intensity laser treatmentHigh 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 | Device | high intensity laser treatment |
| ExercisesPatients in all treatment groups received the same standardized rehabilitation programme consisting of facial massage, mirror exercises, and resisted facial and neck exercise | Other | Low-Level Laser Therapy, high intensity laser treatment, sham laser therapy |
Primary outcome
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 Facial-nerve distal latency and CMAP amplitude at the nasalis.
1 secondary outcome
secondary Outcome
Time frame: Both at baseline and at 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy, gallium arsenide diode laser (BTL-5000 laser) and high intensity laser treatment in people with Neuropathy, Facial and Bell Palsy, run by Kafrelsheikh University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of Compound motor action potential of facial nerve (time frame: at baseline and after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.