ISRCTN14943354已完成不适用
A prospective, single-centre, randomised, double-blind, placebo-controlled trial to assess the analgesic effects of one-week treatment with anti-tumour necrotising factor (TNF) in patients with lower back and leg pai
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)0 个研究点目标入组 40 人开始时间: 2006年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Patients must be willing and able to give written informed consent prior to admission to the study
- •2. Patients must be American Society of Anesthesiologists (ASA) grade I - III
- •3. Patients must be aged 18 - 65 years
- •4. Patients must be scheduled to undergo epidural steroid injection (ESI) for lower back pain of more than one month's duration and up to nine months
- •5. Patients must have had a chest X-ray prior to admission to the study, within the last six months
- •6. Females of the childbearing age must have a negative urine pregnancy test on the day of the study, and be using an acceptable method of contraception
排除标准
- •1. A history of diabetes mellitus
- •2. A history of uncontrolled chronic disease
- •3. Evidence of immunosupression (including current steroid treatment), immunodeficiency or human immunodeficiency virus (HIV) positive status
- •4. History of tuberculosis (TB)
- •5. Pain for less than one month or more than nine months duration
- •6. Previous back surgery
- •7. Previous chronic pain interventions
- •8. Presence of any of the following:
- •8.1. Recent bowel or bladder disturbance
- •8.2. Motor deficit
- •8.3. Saddle anaesthesia
- •8.4. Suspected malignancy (primary or secondary)
- •9. Any other back pain 'red flag' symptoms and signs, identified by the patient's clinicians or the study investigators
- •10. A history of spinal or neurological disease
- •11. A history of congestive cardiac failure
- •12. Known hypersensitivity to anti-TNF
- •13. A history of previous administration of anti-TNF
- •14. Any contraindications to anti-TNF in the Summary of Product Characteristics
- •15. Pregnancy or lactation
- •16. Patients who are unwilling or unable to conform to the protocol
研究者
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