跳至主要内容
临床试验/NCT01390090
NCT01390090撤回不适用

Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections: Does Accuracy Improve Efficacy?

University of Florida0 个研究点开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Ultrasound evaluation of fluoroscopically guided needle placement in the piriformis muscle.

研究概览

简要总结

Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be scheduled for a piriformis muscle (PM) corticosteroid injection.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject Scheduled to receive piriformis injection for buttock pain
  • Baseline pain visual analogue scale (VAS) value of at least 4 on a scale of 0-10 points
  • Subjective complaint of pain in the buttocks with radiation down the thigh and/or leg
  • Objective clinical diagnosis of piriformis syndrome
  • Reproduction of pain with maneuvers that stretch or contract the piriformis muscle over the sciatic nerve

排除标准

  • Litigation
  • Those receiving long-term (>6 months) remuneration for their pain or seeking new or increased long-term remuneration
  • Those unable to read English and complete the assessment instruments
  • Diagnosis of systemic inflammatory arthritis (e.g. rheumatoid, lupus)
  • Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
  • Possible pregnancy or other reason that precludes the use of fluoroscopy. Fluoroscopy is the current standard of care for piriformis injections. Its use in this study is no different than the standard of care and will be no different if the subjects are enrolling in the study or not
  • Contra-indication to corticosteroid, including known allergies or sensitivities

结局指标

主要结局

Ultrasound evaluation of fluoroscopically guided needle placement in the piriformis muscle.

时间窗: Following fluoroscopic guidance of the needle placement and prior to the injection, the needle position will be evaluated by ultrasound.

Following the fluoroscopically guided needle placement, the non-invasive ultrasound probe will then be placed on the skin with gel and will be used to visualize the needle tip and evaluate the accuracy of the fluoroscopically guided needle placement. Needle placement will be recorded as either inside or outside the piriformis muscle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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