Implementation of the STarT Back Screening Tool

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03671278
• Other study ID #: Unicid20
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Universidade Cidade de Sao Paulo
• Contact: Luciola Costa, PhD
• Phone: 1121781564
• Email: luciola.costa[@]unicid.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• STarT 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Out of pocket costs associated with low back pain	Out of pocket costs will be measured using a 9-dimension cost diary	6 weeks and 3 and 6 months after first consultation at the emergency department.
Primary	Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Adoption at 6 weeks (i.e. at the implementation of treatment after stratification)
Primary	Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Adequacy at 3 months.
Primary	Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Fidelity at 3 months.
Primary	Feasibility from the perspective of the patient	Feasibility will be measured by using 4 constructs (Adoption, adequacy, feasibility and fidelity). These constructs will be measured by using yes/no questions.	Feasibility at 3 months.
Secondary	Pain intensity measured by a 0-10 Pain Numerical Rating Scale	Pain intensity will be measured by an 11-point (0-10) Pain Numerical Rating Scale (Pain NRS). Higher scores indicates higher pain intensity.	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Secondary	Disability measured by the 0-24 Roland Morris Disability Questionnaire	Disability will be measured by the 24-item Roland Morris Disability Questionnaire. Higher scores indicates higher disability.	6 weeks and 3 and 6 months after first consultation at the emergency department.
Secondary	Risk of persistent disability measured by the 0-9 Start Back Screening Tool.	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.	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Secondary	Global Impression of Recovery measured by the -5 to + 5 Global Perceived Effect Scale.	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.	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Secondary	Recovery from pain	Recovery from pain will be measured using a yes/no question (i.e. Were you completely free of back pain over the last month?)	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Secondary	Depressive symptoms over the last week.	Depression will be measured by a single question on how depressed patients were over the last week (measured on a 0-10 likert scale)	1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Secondary	Recurrence of low back pain symptoms	Patients who recovered will be asked if they have experience a recurrence of symptoms	6 weeks and 3 and 6 months after first consultation at the emergency department.