Efficacy of Pregabalin in Patients With Radicular Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Pain Scores (NRS) at 3-weeks
研究概览
简要总结
The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.
详细描述
Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pain in dermatomal distribution, in either cervical or lumbar region.
- •History of pain for more than 3 months.
- •History of herniated disc, spinal stenosis or failed back surgery.
- •A series of epidural steroid injections within the past 6 months.
- •Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
- •Patients must be cognitively capable of completing the pain questionnaires.
排除标准
- •Patients below 18 or over 65 years of age.
- •Patients with mostly axial spinal pain.
- •Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
- •Workmen's compensation or disability issues.
- •Patients with chronic depression and on depression medications.
- •Addiction and/or substance abuse issues.
- •Patients using gabapentin or failure to respond to previous gabapentin use.
- •Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
- •Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
- •History of angioedema with pregabalin use.
- •Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
- •Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
- •Pregnant patients.
研究组 & 干预措施
Pregabalin
A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
干预措施: Pregabalin (Drug)
Surgar Pill
One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
干预措施: Sugar Pill (Drug)
结局指标
主要结局
Pain Scores (NRS) at 3-weeks
时间窗: 3 weeks
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .
次要结局
- Oswestry Disability Questionnaires(3 weeks)
- Patient's Global Impression of Change at 3 Weeks(3 weeks)
研究者
kahlid malik
Assistant Professor of Anesthesiology
Northwestern University