Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Numerical rating scale (NRS)
研究概览
简要总结
The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy
详细描述
Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The assessor and the investigator are unaware of the sequence of the 15 days treatment with pentoxifylline
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral lumbar radiculopathy
- •Disc hernia confirming the diagnosis with radio-clinical concordance
排除标准
- •Radicular deficit needing surgery
- •Cauda equine syndrome
- •Absence of radio-clinical concordance on MRI
- •Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer ...)
- •Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
- •Pregnancy
- •Follow-up not possible
- •Hepatic dysfunction
- •History of drug abuse
- •Current use of tramadol, codeine and/or morphine and its derivative
- •Antidepressant use
研究组 & 干预措施
Control
Ibuprofen
干预措施: Ibuprofen (Drug)
Pentoxifylline
Pentoxifylline oral tablets
干预措施: Pentoxifylline Oral Tablet (Drug)
结局指标
主要结局
Numerical rating scale (NRS)
时间窗: At day 15 (and Day 30)
Pain assessment by NRS
次要结局
- Patient global impression of improvement scale(day 15 and 30)
- Side effects(Day 15 and 30)
研究者
Dr Joseph Maarrawi
Associate Professor : Researcher - Pain Specialist - Neurosurgeon
St Joseph University, Beirut, Lebanon