Low Back PainNCT04691193
The Effect of STarT Back Screening Tool
An observational study of Low Back Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2020to 1 Feb 2021
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient clinic
Who may be able to join
- Above 18 years old
- Low back pain for less than 3 months
- Sign the written informed consent.
- Being able to read and write
Who cannot join
- Inflammatory rheumatologic disease
- Having a history of lumbar surgery
- Back pain for more than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of STarT Back Screening Tool in Determining Prognosis and Workforce Loss in Patients With Acute-Subacute Low Back Pain and Its Relationship With Kinesiophobia
The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.
Read the detailed description
Low back pain (LBP) is a common disorder that affects about 80% of adults at least once in a period of their life. 10% of low back pain becomes chronic and can affect the quality of life negatively and lead to disability. The STarT-Back-Tool was developed to identify people with poor prognosis, such as difficulty returning to work, loss of work force, disability. It has been reported that it would be beneficial to categorize patients according to their risk levels with this tool and plan treatment in primary care treatment centers. Being able to identify patients with a high probability of becoming chronic in the early period is very important to reduce or prevent disability that may occur. The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.
- Conditions
- Low Back Pain
- Keywords
- sTart back secreening tool, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study and control group | The study group included patients with low back pain for less than 3 months. The control group consists of healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STart Back screening Tool
to measure baseline risk of possible future poor outcome.
Measured: within 6 month
Roland Morris Questionnaire
to determine function
Measured: within 6 month
Secondary outcomes (1)
Tampa Scale for Kinesiophobia
to determine kinesiophobia
Measured: at the beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start6 Jul 2020
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, nihal tezel, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Nihal Tezel, Principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691193
- Sponsor's protocol ID
- DiskapiYBERH2
- Status last verified
- Feb 2021
- First submitted
- 23 Dec 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forsbrand MH, Grahn B, Hill JC, Petersson IF, Post Sennehed C, Stigmar K. Can the STarT Back Tool predict health-related quality of life and work ability after an acute/subacute episode with back or neck pain? A psychometric validation study in primary care. BMJ Open. 2018 Dec 22;8(12):e021748. doi: 10.1136/bmjopen-2018-021748.
PubMed 30580256Suri P, Delaney K, Rundell SD, Cherkin DC. Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S. Primary Care Setting. Arch Phys Med Rehabil. 2018 Aug;99(8):1533-1539.e2. doi: 10.1016/j.apmr.2018.02.016. Epub 2018 Apr 3.
PubMed 29625095Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008 May 15;59(5):632-41. doi: 10.1002/art.23563.
PubMed 18438893
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of STarT Back Screening Tool in Determining Prognosis and Workforce Loss in Patients With Acute-Subacute Low Back Pain and Its Relationship With Kinesiophobia
- ClinicalTrials.gov ID
- NCT04691193
- Acronym / sponsor ID
- DiskapiYBERH2
- Conditions
- Low Back Pain
- Keywords
- sTart back secreening tool, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 31 Dec 2020 (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 aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.
Detailed description
Low back pain (LBP) is a common disorder that affects about 80% of adults at least once in a period of their life. 10% of low back pain becomes chronic and can affect the quality of life negatively and lead to disability. The STarT-Back-Tool was developed to identify people with poor prognosis, such as difficulty returning to work, loss of work force, disability. It has been reported that it would be beneficial to categorize patients according to their risk levels with this tool and plan treatment in primary care treatment centers. Being able to identify patients with a high probability of becoming chronic in the early period is very important to reduce or prevent disability that may occur. The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study and control group | – | –The study group included patients with low back pain for less than 3 months. The control group consists of healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic
Key inclusion criteria (4 listed)
- Above 18 years old
- Low back pain for less than 3 months
- Sign the written informed consent.
- Being able to read and write
Key exclusion criteria (3 listed)
- Inflammatory rheumatologic disease
- Having a history of lumbar surgery
- Back pain for more than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
STart Back screening Tool
Time frame: within 6 month
to measure baseline risk of possible future poor outcome.
Roland Morris Questionnaire
Time frame: within 6 month
to determine function
1 secondary outcome
Tampa Scale for Kinesiophobia
Time frame: at the beginning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 30580256Forsbrand MH, Grahn B, Hill JC, Petersson IF, Post Sennehed C, Stigmar K. Can the STarT Back Tool predict health-related quality of life and work ability after an acute/subacute episode with back or neck pain? A psychometric validation study in primary care. BMJ Open. 2018 Dec 22;8(12):e021748. doi: 10.1136/bmjopen-2018-021748.
- Background: PubMed 29625095Suri P, Delaney K, Rundell SD, Cherkin DC. Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S. Primary Care Setting. Arch Phys Med Rehabil. 2018 Aug;99(8):1533-1539.e2. doi: 10.1016/j.apmr.2018.02.016. Epub 2018 Apr 3.
- Results publication: PubMed 18438893Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008 May 15;59(5):632-41. doi: 10.1002/art.23563.
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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.
Nihal Tezel principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STart Back screening Tool (time frame: within 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691193, which also lists 3 linked publications.
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 5 Feb 2021.