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Implementation of the STarT Back Screening Tool

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ClinicalTrials.gov Identifier: NCT03671278
Recruitment Status : Unknown
Verified September 2018 by Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: STarT Back Screening Tool Approach Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
STarT Back Screening Tool Approach
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility from the perspective of the patient [ Time Frame: Adoption 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.

  2. Feasibility from the perspective of the patient [ Time Frame: Adequacy 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.

  3. Feasibility from the perspective of the patient [ Time Frame: Fidelity 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.

  4. Feasibility from the perspective of the patient [ Time Frame: Feasibility 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 :
  1. Pain intensity measured by a 0-10 Pain Numerical Rating Scale [ Time Frame: 1, 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.

  2. Disability measured by the 0-24 Roland Morris Disability Questionnaire [ Time Frame: 6 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.

  3. Risk of persistent disability measured by the 0-9 Start Back Screening Tool. [ Time Frame: 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.

  4. Global Impression of Recovery measured by the -5 to + 5 Global Perceived Effect Scale. [ Time Frame: 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.

  5. Recovery from pain [ Time Frame: 1, 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?)

  6. Depressive symptoms over the last week. [ Time Frame: 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)

  7. Recurrence of low back pain symptoms [ Time Frame: 6 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


Other Outcome Measures:
  1. Out of pocket costs associated with low back pain [ Time Frame: 6 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671278


Contacts
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Contact: Luciola Costa, PhD 1121781564 luciola.costa@unicid.edu.br

Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Investigators
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Principal Investigator: Luciola Costa, PhD Universidade Cidade de São Paulo
More Information
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Responsible Party: Luciola da Cunha Menezes Costa, Principal Investigator, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT03671278    
Other Study ID Numbers: Unicid20
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We can share our dataset upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo:
low back pain
emergency
feasibility
implementation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations