The Effect of STarT Back Screening Tool | NCT04691193

Studies
The Effect of STarT Back Screening Tool

NCT04691193

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Status

Completed

Last Update Posted

Feb 5, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2020Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Feb 1, 2021Actual

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Dec 30, 2020

First Posted Date

Dec 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2021

Last Update Posted Date

Feb 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nihal tezel, medical doctor, Diskapi Yildirim Beyazit Education and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Yildirim Beyazit Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
STart Back screening Tool	to measure baseline risk of possible future poor outcome.	within 6 month
Roland Morris Questionnaire	to determine function	within 6 month

Secondary Outcomes

Measure	Description	Time Frame
Tampa Scale for Kinesiophobia	to determine kinesiophobia	at the beginning

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Above 18 years old
Low back pain for less than 3 months
Sign the written informed consent.
Being able to read and write

Exclusion Criteria:

Inflammatory rheumatologic disease
Having a history of lumbar surgery
Back pain for more than 3 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

outpatient clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nihal Tezel	Diskapi Yildirim Beyazit Education and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DiskapiYBERH		Ankara		06010	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30580256	Background	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.
29625095

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms