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临床试验/NCT03968185
NCT03968185已完成不适用

Interfascial Infiltration to Relieve Functional Impairment in Patients Presenting to the Emergency Department for Acute Unspecific Low Back Pain: a Prospective Comparative Feasibility Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Improvement in functional impairment

研究概览

简要总结

Pain relief and functional impairment have been shown to remain poor to moderate over weeks after emergency department discharge, in patients who seek ED management for acute nontraumatic, nonradicular low back pain.

The investigators made the hypothesis that ultrasound-guided interfascial infiltration of local anesthesics and corticoid is efficient and safe in treating patients presenting to the ED with acute non specific low back pain. The investigators aimed to compare early and short term functional impairment and pain relief one day and 1 week after interfacial infiltration, as compared to standard medical treatment

详细描述

This is a single center observational feasibility study enrolling ED patients presenting with acute unspecific low back pain.

Ultrasound-guided interfascial infiltration is proposed to eligible patients presenting to our ED with low back pain and disability, as part of routine care. Patients receive standard medical treatment if they refuse interfascial infiltration or in case of absence or unavailability of a trained operator.

Patients were followed-up at 1 day and 7-days pots ED discharge by telephone interview conducted by an independent member of our research team not involved in patient's management

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged between 18 and 70 years old
  • presenting to the ED for low back pain from musculoskeletal origin, with symptoms evolving for less than 6 weeks,
  • a score of 3 or more in the numeric pain scale (0-10)
  • a score of 5 or greater on the Rolland Morris Disability Questionary (scale 0-24, RMDQ).

排除标准

  • Traumatic or radicular pain or low back pain from alternative etiology
  • allergy to local anesthetics
  • Blood coagulation disorders
  • Patients for whom follow-up by telephone interview was not possible
  • Patients already enrolled in the study

结局指标

主要结局

Improvement in functional impairment

时间窗: 1 day

Improvement in functional impairment as measured on the Roland-Morris Disability Questionnaire (RMQD), ranging from 0 no functional impairment to 24 severe disability

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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