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临床试验/NCT03671278
NCT03671278Unknown不适用

Implementing the STarT Back Model of Stratifying Care for Patients With Low Back Pain Seeking Care in an Emergency Department: a Prospective Longitudinal Cohort Study

Universidade Cidade de Sao Paulo0 个研究点目标入组 200 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Feasibility from the perspective of the patient

研究概览

简要总结

The STarT Back Screening Tool (SBST) has been used in different healthcare settings in order to stratify the management of patients with low back pain. However, to date, no study has investigated the feasibility of implementing the SBST in emergency departments. The objective of this study will be to test the implementation of the SBST in the stratification of patients seeking care in emergency departments.

详细描述

The Start Back Screening Tool (SBST) aims to identify and stratify primary care patients by using modifiable prognostic indicators that are relevant in clinical decision making. The objective of this study will be to test the feasibility of the implementation of the SBST in the stratification of patients seeking care in emergency departments. Study design: A prospective longitudinal cohort study with a 6-month follow-up. Intervention: At 6-weeks after baseline consultation, patients will be targeted to the specific treatment according to their subclassification in the SBST tool: education about pain neurophysiology and physical therapy. This is the first study that will provide results about logistic processes of the implementation of the SBST in the emergency sector, present feasibility data for the conduction of a large randomized controlled trial of subgroups of low back pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

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

  • We will include patients with back pain seeking care in emergency departments

排除标准

  • We will exclude patients with serious spinal pathologies (such as cancer, fractures, inflammatory and infectious diseases) as well as pregnant patients and patients with nerve root compromise.

研究组 & 干预措施

STarT Back Screening Tool Approach

Other

After baseline consultation, all patients will receive usual care from their medical doctors as well as an educational booklet and weekly videos containing information on the prognosis of back pain and how patients could deal with their problems. Six weeks after baseline consultation all patients will be screened by the STarT Back Screening Tool (SBST) and will receive a stratified care according to their SBST classification.

干预措施: STarT Back Screening Tool Approach (Other)

结局指标

主要结局

Feasibility from the perspective of the patient

时间窗: Feasibility at 3 months.

Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.

次要结局

  • Global Impression of Recovery measured by the -5 to + 5 Global Perceived Effect Scale.(1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.)
  • Recovery from pain(1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.)
  • Pain intensity measured by a 0-10 Pain Numerical Rating Scale(1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.)
  • Disability measured by the 0-24 Roland Morris Disability Questionnaire(6 weeks and 3 and 6 months after first consultation at the emergency department.)
  • Risk of persistent disability measured by the 0-9 Start Back Screening Tool.(1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.)
  • Depressive symptoms over the last week.(1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.)
  • Recurrence of low back pain symptoms(6 weeks and 3 and 6 months after first consultation at the emergency department.)

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciola da Cunha Menezes Costa

Principal Investigator

Universidade Cidade de Sao Paulo

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