Low Back PainNCT03671278
Implementation of the STarT Back Screening Tool
A study testing STarT Back Screening Tool Approach in people with Low Back Pain, run by Universidade Cidade de Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- STarT Back Screening Tool Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include patients with back pain seeking care in emergency departments
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- STarT Back Screening Tool Approach
- Keywords
- low back pain, emergency, feasibility, implementation
- Medical subject headings
- Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STarT Back Screening Tool ApproachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STarT Back Screening Tool Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Feasibility at 3 months.
Secondary outcomes (7)
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.
Measured: 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
Disability will be measured by the 24-item Roland Morris Disability Questionnaire. Higher scores indicates higher disability.
Measured: 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.
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.
Measured: 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.
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.
Measured: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
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?)
Measured: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
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)
Measured: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Recurrence of low back pain symptoms
Patients who recovered will be asked if they have experience a recurrence of symptoms
Measured: 6 weeks and 3 and 6 months after first consultation at the emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo
- Investigators
- Luciola Costa, PhD, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671278
- Sponsor's protocol ID
- Unicid20
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We can share our dataset upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03671278
- Acronym / sponsor ID
- Unicid20
- Conditions
- Low Back Pain
- Keywords
- low back pain, emergency, feasibility, implementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STarT Back Screening Tool Approach | Other | Other: STarT Back Screening Tool ApproachAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include patients with back pain seeking care in emergency departments
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STarT Back Screening Tool ApproachPatients 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. | Other | STarT Back Screening Tool Approach |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
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.
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.
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.
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.
Recovery from pain
Time frame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Depressive symptoms over the last week.
Time frame: 1, 2, 6 weeks and 3 and 6 months after first consultation at the emergency department.
Recurrence of low back pain symptoms
Time frame: 6 weeks and 3 and 6 months after first consultation at the emergency department.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: Undecided. We can share our dataset upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciola Costa, PhD principal investigator
Universidade Cidade de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing STarT Back Screening Tool Approach in people with Low Back Pain, run by Universidade Cidade de Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luciola Costa, PhD (1121781564, luciola.costa@unicid.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility from the perspective of the patient (time frame: Adoption at 6 weeks (i.e. at the implementation of treatment after stratification)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.