High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia (a Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Trigeminal neuralgia (TN) is the most common and severe type of neuropathic pain disorder affecting the orofacial region. It is characterized by sudden, intense, episodic attacks of pain in the distribution of trigeminal nerve, usually unilateral. The condition severely impairs patient's quality of life. TN represents a diagnostic and therapeutic challenge, pharmacological therapy remains the first-line management, and many patients experience reduced drug tolerance or significant side effects over time. Surgical options are considered for refractory cases but are invasive and carry risks such as infection, nerve damage, and recurrence of symptoms. In recent years, laser based therapies have gained attention as safe, non-invasive alternatives. Low level laser therapy (LLLT) promotes photo-biomodulation and nerve repair without thermal damage, while high-intensity laser therapy (HILT) can achieve deeper penetration and direct neuromodulation. However, comparative evidence regarding their efficacy in TN is still limited. Aim: The present study aims to evaluate and compare the effect of High intensity laser therapy and low level laser therapy in reducing pain intensity and improving quality of life in patients with trigeminal neuralgia.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria.
- •Patients with drug refractory trigeminal neuralgia (defined as poor response to adequate pharmacological treatment or intolerance to side effects for at least three months).
- •Patients who are contraindicated for surgical intervention or any other interventions, or who have previously undergone such interventions without obtaining satisfactory pain relief.
排除标准
- •patients with secondary trigeminal neuralgia diagnosed with brain lesions that is indicated for surgery (percutaneous procedures, gamma knife, microvascular decompression).
- •Patients with other orofacial conditions such as temporomandibular disorders, migraine, or other neurological diseases.
- •Patients with contraindications to laser use (e.g., pacemakers).
- •Patients who are responding well to medical treatment.
- •Pregnant or lactating women.
研究组 & 干预措施
Nd-YAG Laser
干预措施: 1064 nm Nd-YAG Laser (Other)
Diode laser
干预措施: 940 nm Diode laser (Other)
结局指标
主要结局
Change in pain scores
时间窗: up to 12 weeks
Subjective Pain score as measured by Numerical Rating Scale (NRS) \[26\] . Pain will be measured at baseline and at weeks 1, 2, 3, 4, 8, and 12
Change in quality of life
时间窗: up to 12 weeks
it will be assessed using OHIP-14 questionnaire at baseline, and 4, 8, 12 weeks.
次要结局
未报告次要终点