EUCTR2005-003722-26-GB进行中（未招募）不适用
A prospective, single centre, randomised, double-blind, placebo controlled trial to assess the analgesic effects of one week treatment with anti-TNF in patients with lower back and leg pain. - Pilot study of anti-TNF use in lower back and leg pain patientsw
Barts and the London NHS Trust0 个研究点目标入组 40 人开始时间: 2005年12月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A potential participant must be willing and able to give written informed consent prior to admission to the study.
- •Participant must be ASA I-III.
- •Participant must be aged 18-65
- •Participant must be deemed suitable to be scheduled for an epidural steroid injection for lower back and leg pain of more than one month's duration and up to nine months.
- •Participant must have a chest X-ray prior to admission to the study, within the last six months (to exclude TB and malignancy)
- •Females of childbearing age must have a negative urine pregnancy test on the day of the study and must be using an acceptable method of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A history of diabetes mellitus
- •A history of uncontrolled chronic disease
- •Evidence of immunosupression (including current steroid treatment, immunodeficiency or HIV positive status)
- •A history of TB
- •Pain less than a month or more than nine months duration
- •Previous back surgery
- •Previous chronic pain interventions
- •Presence of any of the following: 1) recent bowel or bladder disturbance, 2) motor deficit, 3) saddle anaesthesia, 4) suspected malignancy (primary or secondary)
- •A history of spinal or neurological disease
- •A history of congestive heart failure
- •Known hypersensitivity to anit-TNF (Enbrel)
- •Any contraindications to anti-TNF (Enbrel) in the Summary of Product Characteristics
- •Pregnancy or lactation
- •Patients who are unwilling or unable to conform to the protocol.
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