Effect of Non-invasive Photobiomodulation Therapies in Patients With Trigeminal Neuralgia: A Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4.
研究概览
简要总结
The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN).
详细描述
The aim of this study was to compare the effectiveness of two different photobiomodulation (PBM) therapies as an alternative to medical treatment to reduce pain and improve quality of life in patients with trigeminal neuralgia (TN). A total of 45 patients with mean age of 46.09 years (26 female, 19 male) were randomly divided into three groups. The first group received PBM therapy with a new generation diode laser (NGD laser). In the second group, low-level Nd:YAG laser was applied along the affected nerve line and the placebo group received the same protocol with Nd:YAG laser without the device switched on. The scores were recorded before and after the treatment using the Brief Pain Inventory-facial (BPI-facial) scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with idiopathic trigeminal neuralgia as defined by the International Headache Society (2).
- •Patients diagnosed with idiopathic trigeminal neuralgia and receiving medical treatment (carbamazepine, etc.)
- •Patients with unilateral, severe, sudden onset of facial pain along the branches of the trigeminal nerve.
- •Patients who have not previously received any interventional treatment for TN.
- •Patients recently diagnosed and started on a first dose of carbamazepine and its derivatives
排除标准
- •• Patients diagnosed with type 2 (atypical, symptomatic) trigeminal neuralgia as defined by the International Headache Society (2).
- •Patients with etiologies such as tumour, multiple sclerosis or neurovascular compression on radiography.
- •Pregnant women
- •Patients with systemic diseases such as diabetes, cardiovascular disease, hypertension, etc.
- •Patients who have been previously diagnosed and treated with any type of TN therapy.
结局指标
主要结局
Change from baseline in pain intensity on the 10 point Brief Pain Inventory-facial scale at week 4.
时间窗: baseline and week 4
Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the average pain intensity over the past 24 hour period. The scores range from 0: no pain, 10: the worst pain you can imagine change= week 4 score-baseline score
Change from baseline in interference in general activities on the 10 point Brief Pain Inventory-facial scale at week 4.
时间窗: baseline and week 4
Brief Pain Inventory-facial scale is a validated, self-reported scale assessing the interference in general activities over the past 24 hour period. The scores range from 0: no inhibition, 10: complete inhibition change= week 4 score-baseline score
次要结局
- Change from baseline in interference in face specific activities on the 10 point Brief Pain Inventory-facial scale at week 4.(baseline and week 4)
研究者
İREM KARAGOZOGLU
Assist. Prof.
University of Gaziantep