Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS))
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS): Pain ruler done daily
研究概览
简要总结
This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve pain worldwide
详细描述
The treatment of neuropathic pain is clinically challenging, and pain from cervical spondylosis (CS) is a common variant. This may result from degenerative spinal canal/cord stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)).
Pregabalin is a newly registered drug for the treatment of neuropathic pain. Its efficacy has been proven in randomised, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. However, its efficacy in CS with underlying CSR or CSM has not been established. Additionally, there are no data to date on its use in Asian patients.
In this study, we prospectively evaluate its efficacy for treating neuropathic pain in degenerative CSR/ CSM 60 patients in an open-labelled, add on fashion. Self-evaluation and investigator rated scoring will be implemented.
The results will be of value in the non-operative management of CS.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical & MRI, or electrophysiological evidence of pain due to radiculopathy
- •Patients with CS and CSR or CSM with neuropathic pain due to the above in the neck and upper limbs or lower limbs (including dysesthesia, paresthesia, hyperalgesia).
排除标准
- •Diabetic neuropathy or other underlying neuropathic conditions
- •Contraindications and allergy to pregabalin
- •Previously treated with gabapentin in the last 8 weeks
- •Pregnant or breast feeding
- •History of renal impairment
- •History of other causes of neuropathic pain
结局指标
主要结局
Visual Analogue Scale (VAS): Pain ruler done daily
时间窗: 2 months
次要结局
- Short-Form McGill Pain Questionnaire (SFMPQ)(0, 1, 2 months)
- Patient and Clinical Global Impression of change(0, 1, 2 months)