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Implementation of the STarT Back Screening Tool

Not Applicable
Conditions
Low Back Pain
Interventions
Other: STarT Back Screening Tool Approach
Registration Number
NCT03671278
Lead Sponsor
Universidade Cidade de Sao Paulo
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria
  • We will include patients with back pain seeking care in emergency departments
Exclusion Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
STarT Back Screening Tool ApproachSTarT Back Screening Tool ApproachAfter 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.
Primary Outcome Measures
NameTimeMethod
Feasibility from the perspective of the patientFeasibility 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.

Secondary Outcome Measures
NameTimeMethod
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.

Global Impression of Recovery will be measured using the 11-item Global Perceived Effect Scale. Positive values represents recovery and negative values represents deterioration of symptoms.

Recovery from pain1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.

Recovery from pain will be measured using a yes/no question (i.e. Were you completely free of back pain over the last month?)

Pain intensity measured by a 0-10 Pain Numerical Rating Scale1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.

Pain intensity will be measured by an 11-point (0-10) Pain Numerical Rating Scale (Pain NRS). Higher scores indicates higher pain intensity.

Disability measured by the 0-24 Roland Morris Disability Questionnaire6 weeks and 3 and 6 months after first consultation at the emergency department.

Disability will be measured by the 24-item Roland Morris Disability Questionnaire. Higher scores indicates higher disability.

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.

Risk of persistent disability will be measured using the 0-9 point Start Back Screening Tool. The higher the score the higher is the risk of persistent disability.

Depressive symptoms over the last week.1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.

Depression will be measured by a single question on how depressed patients were over the last week (measured on a 0-10 likert scale)

Recurrence of low back pain symptoms6 weeks and 3 and 6 months after first consultation at the emergency department.

Patients who recovered will be asked if they have experience a recurrence of symptoms

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