Low Back PainNCT06049719
Reliabılıty,Validity Of The Turkish Version Of The NIH-Minimal Dataset
An observational study of Low Back Pain, run by Gazi University at 3 sites in Turkey (Türkiye).
Trial summary
This study, we performed the Turkish version validity and reliability of the NIH Task Force's Recommended Multidimensional Minimal Dataset Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- NIH Task Force's Recommended Multidimensional Minimal Dataset
- How many people
- 245 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 18 years of age with chronic low back pain.
Who may be able to join
- Having a low back pain Literate
Who cannot join
- pregnant,
- canser
- trauma
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Gazi University
Ankara, 06500
Gokhan MARAS
Ankara, 06500
Gökhan maraş
Ankara, 06500
About this study
Official title: 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
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- NIH Task Force's Recommended Multidimensional Minimal Dataset
- Keywords
- validity, reliability, low back apain, translation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIH Task Force's Recommended Multidimensional Minimal DatasetOther
Also called Turkish version of the NIH Task Force's Recommended Multidimensional Minimal Dataset
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Patients with low back pain (18-65 years) Receives: Other: NIH Task Force's Recommended Multidimensional Minimal Dataset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minute
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
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÖKHAN MARAŞ, Gazi University
- Investigators
- Seyit Citaker, Prof., Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049719
- Sponsor's protocol ID
- 2022-18-2
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06049719
- Acronym / sponsor ID
- 2022-18-2
- Conditions
- Low Back Pain
- Keywords
- validity, reliability, low back apain, translation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, we performed the Turkish version validity and reliability of the NIH Task Force's Recommended Multidimensional Minimal Dataset
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: NIH Task Force's Recommended Multidimensional Minimal DatasetPatients with low back pain (18-65 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age with chronic low back pain.
Key inclusion criteria (1 listed)
- Having a low back pain Literate
Key exclusion criteria (3 listed)
- pregnant,
- canser
- trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIH Task Force's Recommended Multidimensional Minimal DatasetAlso: Turkish version of the NIH Task Force's Recommended Multidimensional Minimal DatasetQuestionnaire | Other | Patients group |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: Yes
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyit Citaker, Prof. study chair
Gazi University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Gazi University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris disability questionnaire (time frame: 10 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.