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临床试验/NCT03618589
NCT03618589Unknown1 期

Comparison of Effectiveness of Opioid Only and Pregabalin add-on for the Treatment of Neuropathic Pain in Cervical Myelopathy Patients

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
60
试验地点
1
主要终点
Leeds assessment of neuropathic symptoms and signs (LANSS) and visual analogue scale (VAS)

研究概览

简要总结

There is no information on the effect of pregabalin in patients with neuropathic pain in cervical myelopathy under routine clinical practice.

The investigators will conduct this prospective, randomized trial to determine the efficacy of pregabalin for neuropathic pain in cervical myelopathic patients in order to validate or refute this popular practice. The primary aim of this study was to compare Leeds assessment of neuropathic symptoms and signs scale (LANSS) scores of neuropathic pain in cervical myelopathy patients.

详细描述

Neuropathic pain is a well-recognized clinical entity. It is defined as pain caused by the lesion or dysfunction of the peripheral or central nervous system, and it can be diagnosed by well-established clinical criteria. Neuropathic pain is caused by lesions or dysfunction of the nervous system and is initiated by several cellular and molecular mechanisms. Compression of neural and neurovascular structures may result in neuropathic pain. Although a number of therapies are available for neuropathic pain, including antidepressants, tramadol, opioids, and different antiepileptic drugs, the results of a recent systematic review suggest that, in view of their balance between efficacy and tolerability, pregabalin can be regarded as first line treatments for peripheral pain with a neuropathic component.

Pregabalin is one of antiepileptic drugs (AEDs) that have been studied in the treatment of a wide variety of disorders, such as neuropathic pain, epilepsy, spasticity, and anxiety. The use of AEDs in the treatment of neuropathic pain is based on a number of similarities in the pathophysiologic and biochemical mechanisms underlying neuropathic pain and epilepsy. Its use for the treatment of several neuropathic pain syndromes is common, and it is approved by the Food and Drug Administration (FDA) for the treatment of diabetic neuropathy, post-herpetic neuralgia, fibromyalgia and spinal cord injury, a model of central neuropathic pain. The off-label use of pregabalin for the various pain syndromes in general, and for neuropathic pain in particular, is ubiquitous. However, minimal support for this practice exists in the literature and its cost is perhaps exorbitant. There is no information on the effect of pregabalin in patients with neuropathic pain in cervical myelopathy under routine clinical practice.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages of 18 to 80 years
  • Among patients with cervical myelopathy, patients with neuropathic pain (LANSS pain scale ≥ 12)
  • Completing 8-week drug trial

排除标准

  • Current or prior gabapentin or pregabalin use
  • Chronic use of narcotic pain medications
  • Chronic depression or the use of anti-depressants
  • History of addiction and/or substance abuse
  • Presence of significant motor deficits, and /or bowel and/or bladder dysfunction
  • Known renal insufciency, diabetes, congestive heart failure, cardiac conduction abnormalities, and thrombocytopenia

研究组 & 干预措施

opioid only

Placebo Comparator

Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.

干预措施: Opioid (Drug)

pregabalin add-on

Experimental

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

干预措施: Pregabalin (Drug)

pregabalin add-on

Experimental

Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.

干预措施: Opioid (Drug)

结局指标

主要结局

Leeds assessment of neuropathic symptoms and signs (LANSS) and visual analogue scale (VAS)

时间窗: 2 months

The LANSS pain scales are used globally to screen for the presence of pain of neuropathic origin because they have high sensitivity and specificity compared with other available tools. It rages from 0 to 24. The LANSS scores ≧12 suggest the presence of neuropathic pain. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. It ranges from 0 to 10 (0 means no pain, 10 means worst pain.

次要结局

  • neck disability index (NDI) and EuroQol- 5 Dimension (EQ-5D)(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chun Kee Chung

professor

Seoul National University Hospital

研究点 (1)

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