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this study was done to compare different laser frequencies on neuropathic outcomes in patients with Bell's palsy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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) |
|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Eid Lafi Aljohani, physical therapist | Contact | 00966564988366 | pt.ahmad3@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| outpatient clinic, Department of physical therapy at King Fahd Hospital in Almadinah Almunawwarah. | Recruiting | Madinah | Saudi Arabia |
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| 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. |
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| 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 |
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| 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 |
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| ID | Term |
|---|---|
| D005155 | Facial Nerve Diseases |
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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