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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04691193
Other study ID # DiskapiYBERH2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 6, 2020
Est. completion date February 1, 2021

Study information

Verified date February 2021
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey DiskapiYBERH Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Hill 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. — View Citation

Suri 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary STart Back screening Tool to measure baseline risk of possible future poor outcome. within 6 month
Primary Roland Morris Questionnaire to determine function within 6 month
Secondary Tampa Scale for Kinesiophobia to determine kinesiophobia at the beginning
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