Low Back PainNCT03298490
Reliability, Validity Of The Turkish Version Of The Back Performance Scale
An observational study of Low Back Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we performed the validity and reliability of the Turkish version of Back Performance 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
- 5 Apr 2017to 18 Nov 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 persons
Who cannot join
- Cancer disease
- Trauma
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we performed the validity and reliability of the Turkish version of Back Performance Scale.
Read the detailed description
Low back pain (LBP) is defined as the pain that occurs in the area between the lower border of the scapula and the buttocks and sometimes radiates to the lower extremities. In the community, lower back pain is the second most common health problem after cold. 15% of LBP cases are chronic. 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 study is to determine the Turkish version, validity and reliability of Back Performance 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 evaluated using the Intraclass Correlation Coefficient method.
- Conditions
- Low Back Pain
- Keywords
- validity, reliability, low back pain
- Medical subject headings
- Low Back Pain
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 posted2 Oct 2017
- Study start5 Apr 2017
- Primary completion5 Oct 2017
- Study completion18 Nov 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.
- 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
- Case only
- Time perspective
- Prospective
- 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 çıtaker, Study chair, gazi üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298490
- Sponsor's protocol ID
- 2017-73
- Status last verified
- Oct 2019
- First submitted
- 22 Sep 2017
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity Of The Turkish Version Of The Back Performance Scale
- ClinicalTrials.gov ID
- NCT03298490
- Acronym / sponsor ID
- 2017-73
- 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
- 5 Apr 2017 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 18 Nov 2017 (actual)
- First posted
- 2 Oct 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.
In this study, we performed the validity and reliability of the Turkish version of Back Performance Scale.
Detailed description
Low back pain (LBP) is defined as the pain that occurs in the area between the lower border of the scapula and the buttocks and sometimes radiates to the lower extremities. In the community, lower back pain is the second most common health problem after cold. 15% of LBP cases are chronic. 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 study is to determine the Turkish version, validity and reliability of Back Performance 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 evaluated using the Intraclass Correlation Coefficient method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 (2 listed)
- Having a low back pain
- Literate persons
Key exclusion criteria (3 listed)
- Cancer disease
- Trauma
- Pregnant
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 4 Oct 2019.
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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 çıtaker 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 2 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 4 Oct 2019. 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 4 Oct 2019.