Low Back PainNCT03175510
Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale
An observational study of Low Back Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study, we performed the Turkish version validity and reliability of the Back Pain Function Scale. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2016to 1 Sep 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic back pain between the ages of 18-65
Who may be able to join
- Having a low back pain Literate
Who cannot join
- pregnant canser trauma
Trial locations and contacts
1 site in 1 country.
About this study
This study, we performed the Turkish version validity and reliability of the Back Pain Function Scale.
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 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.
- Conditions
- Low Back Pain
- Keywords
- validity, reliability, low back pain
- 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.
| Study group | Role | What they receive |
|---|---|---|
| patients group | Patients with low back pain (18-65 years) |
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
Secondary outcomes (1)
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 posted5 Jun 2017
- Study start15 May 2016
- Primary completion1 Aug 2017
- Study completion1 Sep 2017
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
- 180 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, Study chair, gazi üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175510
- Sponsor's protocol ID
- 2017-72
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale
- ClinicalTrials.gov ID
- NCT03175510
- Acronym / sponsor ID
- 2017-72
- Conditions
- Low Back Pain
- Keywords
- validity, reliability, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 5 Jun 2017 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients group | – | –Patients with low back pain (18-65 years) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic back pain between the ages of 18-65
Key inclusion criteria (1 listed)
- Having a low back pain Literate
Key exclusion criteria (1 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.
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.
1 secondary outcome
Oswestry Low Back Pain Disability Questionnaire
Time frame: 10 minute
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 25 Sep 2017.
- Individual participant dataSharing planned: Yes
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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 study chair
gazi üniversity
1 site 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 1 site 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 1 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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). 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 25 Sep 2017.