Different Laser Frequencies on Neuropathic Outcomes in Patients With Bell's Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- assessment of Compound motor action potential of facial nerve
研究概览
简要总结
this study was done to compare different laser frequencies on neuropathic outcomes in patients with Bell's palsy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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)
干预措施: Low-Level Laser Therapy (Device)
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)
干预措施: high intensity laser treatment (Device)
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).
干预措施: Exercises (Other)
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)
干预措施: Exercises (Other)
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).
干预措施: sham laser therapy (Device)
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)
干预措施: Exercises (Other)
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)
干预措施: gallium arsenide diode laser (BTL-5000 laser) (Device)
结局指标
主要结局
assessment of Compound motor action potential of facial nerve
时间窗: 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.
次要结局
- secondary Outcome(Both at baseline and at 6 weeks.)
研究者
Ahmed Eid Lafi Aljohani
Principal Investigator
Kafrelsheikh University