Reliabılıty,Validity Of The Turkish Version Of The Back P... | NCT03175510

Studies
Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale

NCT03175510

Sponsor

Gazi University

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

180Actual

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

Jun 2017

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

May 15, 2016Actual

Primary Completion Date

Aug 1, 2017Actual

Completion Date

Sep 1, 2017Actual

First Submitted Date

Jun 1, 2017

First Submission Date that Met QC Criteria

Jun 1, 2017

First Posted Date

Jun 5, 2017Actual

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

Sep 22, 2017

Last Update Posted Date

Sep 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study, we performed the Turkish version validity and reliability of the Back Pain Function Scale.

Detailed Description

Low back pain is defined as the pain that can occur in the region between the lower border of the scapula and the hip, sometimes spreading to the lower extremities, which causes activity limitation and is one of the most common health problems in the society. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of our study is to determine the Turkish version, validity and reliability of Back Pain Function Scale. 180 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results were evaluated using the Intraclass Correlation Coefficient method. Intraclass Correlation Coefficient results vary between 0.857 and 0.951, and the total Intraclass Correlation Coefficient value is found to be 0.961. These results indicate that the test-retest responses have a high degree of correlation. For internal consistency analysis, the Cronbach Alpha score was fou nd to be 0.910, indicating that the survey has high internal consistency. The total score obtained from the Back Pain Function Scale was assessed using the Pearson correlation analysis with the total scores obtained from the Roland Morris Disability Scale , Oswestry Disability Scale. Pearson's correlation coefficient was -0.840 with Oswestry Disability Scale of Back Pain Function Scale, Pearson's correlation coefficient was -0.803 with Roland Morris Disability Scale. The results show that the Back Pain Function Scale correlates perfectly with the Oswestry Disability Scale and the Roland Morris Disability Scale. In conclusion, Turkish version of Bac Pain Function Scale is valid and reliable.

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

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients group		Patients with low back pain (18-65 years)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Roland Morris disability questionnaire	Roland Morris Disability Questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice.	10 minute

Secondary Outcomes

Measure	Description	Time Frame
Oswestry Low Back Pain Disability Questionnaire	The Oswestry Disability Index (ODI) has become one of the principal condition-specific outcome measures used in the management of spinal disorders	10 minute

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having a low back pain Literate

Exclusion Criteria:

pregnant canser trauma

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

Patients with chronic back pain between the ages of 18-65

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
seyit citaker	gazi üniversity	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gazi University		Ankara		06500	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

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

Browse Leaves

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Browse Branches

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