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Implementation of the STarT Back Screening Tool

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03671278
Enrollment
200
Registered
2018-09-14
Start date
2018-10-31
Completion date
2019-12-31
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, emergency, feasibility, implementation

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.

Interventions

OTHERSTarT Back Screening Tool Approach

Patients classified as low risk of persistent pain will be educated about their condition and how to manage their back pain by targeting modifiable prognostic factors. Patients classified as medium risk will receive evidence-based physical therapy. Patients classified as high risk will receive evidence-based physical therapy as well as individualized psychological intervention.

Sponsors

Universidade Cidade de Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility from the perspective of the patientAdoption at 6 weeks (i.e. at the implementation of treatment after stratification)Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.

Secondary

MeasureTime frameDescription
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.
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?)
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
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.

Other

MeasureTime frameDescription
Out of pocket costs associated with low back pain6 weeks and 3 and 6 months after first consultation at the emergency department.Out of pocket costs will be measured using a 9-dimension cost diary

Contacts

Primary ContactLuciola Costa, PhD
luciola.costa@unicid.edu.br1121781564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026