Back PainNCT05267210
Turkish Translation, Validity and Reliability of the Back Pain and Body Posture Assessment Questionnaire
An observational study of Back Pain, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The Adult Back Pain and Body Posture Assessment Instrument (BackPDE-Y), whose validity and reliability is planned, will be applied. This assessment scale will be translated into Turkish by two native Turkish speakers, one who is fluent in English. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Questionnaire
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2021to 2 Sep 2022
- How long will I take part?
- 6 Months
- 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: According to the power analysis, the number of samples was calculated to be at least 10 times the number of items in the scale. 220 people aged between 18-65 will be included in the study.
Who may be able to join
- 18-65 years old Willingness to participate in the study The mother tongue is Turkish, Being able to read and write, - It is between the ages of 18-65.
Who cannot join
- Those with a known or concomitant diagnosis of dementia Not wanting to participate in the study Patients with psychotic disorders, depression with psychotic symptoms, bipolar depression Having a psychiatric illness with a serious psychiatric illness that may prevent the individual from understanding and completing the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Translation, Cultural Adaptation, Validity and Reliability Study of the Back Pain and Body Posture Assessment Questionnaire
The Adult Back Pain and Body Posture Assessment Instrument (BackPDE-Y), whose validity and reliability is planned, will be applied. This assessment scale will be translated into Turkish by two native Turkish speakers, one who is fluent in English.
Read the detailed description
220 people aged between 20-65 are planned to be included in the study. The data obtained from the study will be analyzed with appropriate statistical methods.
In addition, a previously valid and reliable Musculoskeletal System Health Inquiry (MIS-SS) questionnaire, which evaluates the musculoskeletal problems of individuals included in the Study, will be applied. It will be evaluated whether the results of the data obtained from the Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y), which we have validated in Turkish, and the results of the data obtained from the Musculoskeletal Health Questionnaire (CIS-SS) questionnaire are consistent with each other.
- Conditions
- Back Pain
- Being tested
- Questionnaire
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
- Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y) This questionnaire assesses pain and risk factors associated with back pain. The questionnaire includes questions that include demographic, socio-economic, hereditary and behavioral risk factors. The questionarie consists of 20 questions in total.
- Musculoskeletal Health Questionnaire (CIS-SS) The questionnaire included pain/stiffness (during the day and night), physical function (walking and dressing), physical activity level, involvement of symptom-related work/daily life and social activities/hobbies, difficulty sleeping, fatigue, emotional well-being, diagnosis and It consists of a total of 14 questions evaluating the understanding of the treatment and the overall effect of the disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y) total score
The total score will be obtained by adding the points obtained from the answers given to the questionnaire.
Measured: 6 month
Secondary outcomes (1)
Musculoskeletal Health Questionnaire (CIS-SS)
The total score will be obtained by adding the points obtained from the answers given to the questionnaire.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start2 Oct 2021
- Primary completion2 Aug 2022 (estimated)
- Study completion2 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Gökşen, Karamanoğlu Mehmetbey University
- Investigators
- Ayşenur Gökşen, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267210
- Sponsor's protocol ID
- 07-2021/38
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdinc O, Hot K, Ozkaya M. Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire: cross-cultural adaptation and validation. Work. 2011;39(3):251-60. doi: 10.3233/WOR-2011-1173.
PubMed 21709361
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Translation, Cultural Adaptation, Validity and Reliability Study of the Back Pain and Body Posture Assessment Questionnaire
- ClinicalTrials.gov ID
- NCT05267210
- Acronym / sponsor ID
- 07-2021/38
- Conditions
- Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 2 Aug 2022 (estimated)
- Study completion
- 2 Sep 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
The Adult Back Pain and Body Posture Assessment Instrument (BackPDE-Y), whose validity and reliability is planned, will be applied. This assessment scale will be translated into Turkish by two native Turkish speakers, one who is fluent in English.
Detailed description
220 people aged between 20-65 are planned to be included in the study. The data obtained from the study will be analyzed with appropriate statistical methods.
In addition, a previously valid and reliable Musculoskeletal System Health Inquiry (MIS-SS) questionnaire, which evaluates the musculoskeletal problems of individuals included in the Study, will be applied. It will be evaluated whether the results of the data obtained from the Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y), which we have validated in Turkish, and the results of the data obtained from the Musculoskeletal Health Questionnaire (CIS-SS) questionnaire are consistent with each other.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- According to the power analysis, the number of samples was calculated to be at least 10 times the number of items in the scale. 220 people aged between 18-65 will be included in the study.
Key inclusion criteria (1 listed)
- 18-65 years old Willingness to participate in the study The mother tongue is Turkish, Being able to read and write, - It is between the ages of 18-65.
Key exclusion criteria (1 listed)
- Those with a known or concomitant diagnosis of dementia Not wanting to participate in the study Patients with psychotic disorders, depression with psychotic symptoms, bipolar depression Having a psychiatric illness with a serious psychiatric illness that may prevent the individual from understanding and completing the questionnaire
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 |
|---|---|---|
| Questionnaire1. Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y) This questionnaire assesses pain and risk factors associated with back pain. The questionnaire includes questions that include demographic, socio-economic, hereditary and behavioral risk factors. The questionarie consists of 20 questions in total. 2. Musculoskeletal Health Questionnaire (CIS-SS) The questionnaire included pain/stiffness (during the day and night), physical function (walking and dressing), physical activity level, involvement of symptom-related work/daily life and social activities/hobbies, difficulty sleeping, fatigue, emotional well-being, diagnosis and It consists of a total of 14 questions evaluating the understanding of the treatment and the overall effect of the disease. | Other | – |
Primary outcome
Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y) total score
Time frame: 6 month
The total score will be obtained by adding the points obtained from the answers given to the questionnaire.
1 secondary outcome
Musculoskeletal Health Questionnaire (CIS-SS)
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 21709361Erdinc O, Hot K, Ozkaya M. Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire: cross-cultural adaptation and validation. Work. 2011;39(3):251-60. doi: 10.3233/WOR-2011-1173.
- Individual participant dataSharing planned: No
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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.
Ayşenur Gökşen principal investigator
Karamanoğlu Mehmetbey University
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 Back Pain, run by Karamanoğlu Mehmetbey 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: status not confirmed, as of the sponsor's last update on 4 Mar 2022. 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?
Results are not available in the source record.
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?
Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y) total score (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267210, which also lists 1 linked publication.
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 Mar 2022.