NCT04691193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

December 23, 2020

Last Update Submit

February 4, 2021

Conditions

Keywords

sTart back secreening toollow back pain

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Tampa Scale for Kinesiophobia

    at the beginning

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DiskapiYBERH

Ankara, 06010, Turkey (Türkiye)

Location

Related 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.

    PMID: 30580256BACKGROUND
  • 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.

    PMID: 29625095BACKGROUND
  • 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nihal Tezel

    Diskapi Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 31, 2020

Study Start

July 6, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations