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临床试验/NCT02162940
NCT02162940已完成不适用

Effect of Statin Use on Low Back Pain Steroid Injections.

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Low back pain after transforaminal epidural steroid injection assessed by VAS scale.

研究概览

简要总结

The impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to patients not on statins. Secondarily we tested the hypothesis that statin users will have improved quality of life evaluated with Short Form 36 (SF 36).

详细描述

Low back pain is one of the most common complaints for physician office visits and is the most common disorder requiring interventional pain treatment in USA. Fluoroscopy-assisted transforaminal anterior epidural steroid injections (TAESI) are more commonly preferred for treatment of low back pain. Most of the time epidural steroid injections are supplemented with different analgesic combinations due to insufficient analgesia. Recent reports have revealed immunomodulatory and anti-inflammatory activities for statins in vivo and in vitro. Statins have very recently been shown to alleviate neuropathic pain in the rat model. However, the impact of statin use on response to epidural steroid injections remains unknown and may well increase the effect considering the substantial anti-inflammatory properties. We thus tested the primary hypothesis that patients taking statins before and after the procedure will have lower VAS scores compared to patients not on statins. Secondarily we tested the hypothesis that statin users will have improved quality of life evaluated with Short Form 36 (SF 36).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • indication for TAESI given by blinded pain physician

排除标准

  • known allergy to steroids
  • indication for surgery
  • unstable opioid use
  • drug or alcohol abuse within 6 months

结局指标

主要结局

Low back pain after transforaminal epidural steroid injection assessed by VAS scale.

时间窗: 6 months

次要结局

  • Quality of life was evaluated with SF 12 test.(6 months)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SINEM SARI

MD, Assistant Professor

Aydin Adnan Menderes University

研究点 (1)

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