- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049719
Reliabılıty,Validity Of The Turkish Version Of The NIH-Minimal Dataset
March 28, 2024 updated by: GÖKHAN MARAŞ, Gazi University
Translation, Cross-cultural Adaptation and Validation of the Turkish Version of NIH Task Force's Recommended Multidimensional Minimal Dataset for Research on Chronic Low Back Pain
This study, we performed the Turkish version validity and reliability of the NIH Task Force's Recommended Multidimensional Minimal Dataset
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 NIH Task Force's Recommended Multidimensional Minimal Dataset.
200 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.
Study Type
Observational
Enrollment (Actual)
245
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06500
- Gazi University
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Ankara, Turkey, 06500
- Gökhan maraş
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients over 18 years of age with chronic low back pain.
Description
Inclusion Criteria:
- Having a low back pain Literate
Exclusion Criteria:
- pregnant,
- canser
- trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients group
Patients with low back pain (18-65 years)
|
Questionnaire
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Roland Morris disability questionnaire
Time Frame: 10 minute
|
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
|
|
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 10 minute
|
The Oswestry Disability Index (ODI) has become one of the principal condition-specific outcome measures used in the management of spinal disorders
|
10 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Seyit Citaker, Prof., Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
September 19, 2023
First Posted (Actual)
September 22, 2023
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-18-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.