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
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
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
NCT ID
NCT03671278
First Posted
September 5, 2018
Last Updated
September 12, 2018
Sponsor
Universidade Cidade de Sao Paulo
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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