Implementation of the STarT Back Screening Tool

NCT03671278 | Unknown

• 1 other identifier: Unicid20
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

low back pain; emergency; feasibility; implementation

Outcome Measures

Primary Outcomes (4)

• 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)

• 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.

• 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.

• 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 Outcomes (7)

• 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.

• 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.

Other Outcomes (1)

• Out of pocket costs associated with low back pain

  6 weeks and 3 and 6 months after first consultation at the emergency department.

Study Arms (1)

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.

Other: STarT Back Screening Tool Approach

Interventions

STarT Back Screening Tool Approach OTHER

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.

STarT Back Screening Tool Approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

MeSH Terms

Conditions

Low Back Pain; Emergencies

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Luciola Costa, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciola Costa, PhD

CONTACT

1121781564; luciola.costa@unicid.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 14, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 14, 2018

Record last verified: 2018-09