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Implementation of the STarT Back Screening Tool

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STarT Back Screening Tool Approach
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Low Back Pain focused on measuring low back pain, emergency, feasibility, implementation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    STarT Back Screening Tool Approach

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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 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 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 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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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?)
    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)
    Recurrence of low back pain symptoms
    Patients who recovered will be asked if they have experience a recurrence of symptoms

    Full Information

    First Posted
    September 5, 2018
    Last Updated
    September 12, 2018
    Sponsor
    Universidade Cidade de Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03671278
    Brief Title
    Implementation of the STarT Back Screening Tool
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Cidade de Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    low back pain, emergency, feasibility, implementation

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luciola Costa, PhD
    Phone
    1121781564
    Email
    luciola.costa@unicid.edu.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luciola Costa, PhD
    Organizational Affiliation
    Universidade Cidade de São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    We can share our dataset upon request.

    Learn more about this trial

    Implementation of the STarT Back Screening Tool

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