Low Back PainADI_TurkishNCT06700707
Turkish Adaptation, Validity and Reliability Study of the Athlete Disability Index Questionnaire
An observational study of Low Back Pain and Disability, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This survey study aims to analyze the cultural adaptation, validity, and reliability of a scale originally in English and currently being translated into Turkish, which allows athletes with low back pain to assess their functional disabilities in sports and exercise activities as well as their disabilities in daily… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Low Back Pain, Disability, Athlete
- What is being tested?
- Survey using a questionnaire.
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2025to 10 Jun 2025
- How long will I take part?
- 7 Days
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Male and female elite athletes from different sports with low back pain
Who may be able to join
- Low back pain that has persisted for at least 6 weeks
- Pain that worsens with changes in posture, movement, or physical activity
- Elite athletes with a regular training/match schedule of more than 10 hours per week
Who cannot join
- Not knowing Turkish
- Acute inflammatory conditions
- Acute musculoskeletal trauma
- Long-term corticosteroid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Adaptation, Validity and Reliability Study
This survey study aims to analyze the cultural adaptation, validity, and reliability of a scale originally in English and currently being translated into Turkish, which allows athletes with low back pain to assess their functional disabilities in sports and exercise activities as well as their disabilities in daily living activities. Athletes with low back pain will be asked to fill out 3 questionnaires.
Read the detailed description
In the study, firstly, the translation of the Athlete Disability Index Questionnaire (ADI) into the target language, comparison of the two translated versions of the scale, back translation of the preliminary version, synthesis, pilot test of the pre-final version and psychometric test studies will be carried out by 3 independent translators and 2 linguists in 6 stages.
Then, 120 athletes with low back pain will be asked to fill out the ADI, Roland Morris Disability Questionnaire (RMDQ) and Oswestry Low Back Pain Disability Index (ODI). 7 days later, the ADI will be filled out again by 60 athletes.
After the surveys are completed, the structural validity of the scale will be tested, and reliability will be measured by performing test-retest reliability and internal consistency analyses.
- Conditions
- Low Back Pain, Disability, Athlete, Sport
- Being tested
- Survey using a questionnaire.
- 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.
Survey using a questionnaire.Other
Permission was obtained from the original owner of the Athlete Disability Index Questionnaire (ADI) for the Turkish cultural adaptation, validity and reliability study.
120 athletes, determined by the number of questions times the rule of 10, will be asked to fill out the ADI, Oswestry Disability Index (ODI), and Roland-Morris Disability (RMDQ) questionnaires and 60 athletes will be asked to fill out the ADI questionnaire again 7 days later for test-retest reliability.
What is being measured
The primary outcome is the main question the study is designed to answer.
Athlete Disability Index Questionnaire (ADI)
The Athlete Disability Index Questionnaire (ADI) is a self-administered questionnaire to assess disability related to low back pain in athletes. The ADI measures athletes' functional disability in activities of daily living as well as their disability in sports and exercise activities. The ADI consists of 12 questions that include pain intensity, stretching exercises, strengthening/weight training exercises, sport-specific skills (technical skills), rotational waist movements/changing direction, fear of pain or re-injury, sitting, walking, recreational activities, sexual activity, sleep, and personal care (ability to put on socks and shoes, ability to go to the bathroom). Each question is scored from 0 to 3, with higher scores indicating a more severe condition.
Measured: 7 days
Secondary outcomes (2)
Oswestry Low Back Pain Disability Index (ODI)
Oswestry Low Back Pain Disability Index (ODI) is a Likert-type scale that questions pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life and traveling in 10 items. Each item is scored between 0-5 (0: normal, 5: maximum difficulty) and the total score is 50.
In it's calculation; (Final score = [total score] / [(number of marked questions) x5] x 100) formula is used to convert it to a percentage system. A high percentage indicates that the level of disability perceived by the patient is also high. Turkish validity and reliability study has been conducted.
Measured: 1 day
Roland Morris Disability Questionnaire (RMDQ)
Roland Morris Disability Questionnaire (RMDQ): This scale, which was developed by selecting 24 of the 136 items of the Disease Impact Profile, evaluates activity level, daily living activities, eating and sleeping. Yes is scored as 1, no is scored as 0, and a higher total score indicates worse functionality. A Turkish validity and reliability study was conducted by Küçükdeveci et al.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start27 Feb 2025
- Primary completion2 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Aras Bayram, Medipol University
- Investigators
- Gülay Aras Bayram, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700707
- Sponsor's protocol ID
- 20112024
- Acronym
- ADI_Turkish
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zamani E, Kordi R, Nourian R, Noorian N, Memari AH, Shariati M. Low back pain functional disability in athletes; conceptualization and initial development of a questionnaire. Asian J Sports Med. 2014 Dec;5(4):e24281. doi: 10.5812/asjsm.24281. Epub 2014 Nov 10.
PubMed 25741417Aras Bayram G, Ergezen Sahin G, Sahin M, Ustundag B, Kordi R. Cross-cultural adaptation, validity, and reliability of the Turkish version of the athlete disability index. Sci Rep. 2026 Mar 27;16(1):10948. doi: 10.1038/s41598-026-44667-2.
PubMed 41888238
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06700707
- Acronym / sponsor ID
- ADI_Turkish / 20112024
- Conditions
- Low Back Pain, Disability, Athlete, Sport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 22 Nov 2024 (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 survey study aims to analyze the cultural adaptation, validity, and reliability of a scale originally in English and currently being translated into Turkish, which allows athletes with low back pain to assess their functional disabilities in sports and exercise activities as well as their disabilities in daily living activities. Athletes with low back pain will be asked to fill out 3 questionnaires.
Detailed description
In the study, firstly, the translation of the Athlete Disability Index Questionnaire (ADI) into the target language, comparison of the two translated versions of the scale, back translation of the preliminary version, synthesis, pilot test of the pre-final version and psychometric test studies will be carried out by 3 independent translators and 2 linguists in 6 stages.
Then, 120 athletes with low back pain will be asked to fill out the ADI, Roland Morris Disability Questionnaire (RMDQ) and Oswestry Low Back Pain Disability Index (ODI). 7 days later, the ADI will be filled out again by 60 athletes.
After the surveys are completed, the structural validity of the scale will be tested, and reliability will be measured by performing test-retest reliability and internal consistency analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male and female elite athletes from different sports with low back pain
Key inclusion criteria (3 listed)
- Low back pain that has persisted for at least 6 weeks
- Pain that worsens with changes in posture, movement, or physical activity
- Elite athletes with a regular training/match schedule of more than 10 hours per week
Key exclusion criteria (4 listed)
- Not knowing Turkish
- Acute inflammatory conditions
- Acute musculoskeletal trauma
- Long-term corticosteroid use
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 |
|---|---|---|
| Survey using a questionnaire.Permission was obtained from the original owner of the Athlete Disability Index Questionnaire (ADI) for the Turkish cultural adaptation, validity and reliability study. 120 athletes, determined by the number of questions times the rule of 10, will be asked to fill out the ADI, Oswestry Disability Index (ODI), and Roland-Morris Disability (RMDQ) questionnaires and 60 athletes will be asked to fill out the ADI questionnaire again 7 days later for test-retest reliability. | Other | – |
Primary outcome
Athlete Disability Index Questionnaire (ADI)
Time frame: 7 days
The Athlete Disability Index Questionnaire (ADI) is a self-administered questionnaire to assess disability related to low back pain in athletes. The ADI measures athletes' functional disability in activities of daily living as well as their disability in sports and exercise activities. The ADI consists of 12 questions that include pain intensity, stretching exercises, strengthening/weight training exercises, sport-specific skills (technical skills), rotational waist movements/changing direction, fear of pain or re-injury, sitting, walking, recreational activities, sexual activity, sleep, and personal care (ability to put on socks and shoes, ability to go to the bathroom). Each question is scored from 0 to 3, with higher scores indicating a more severe condition.
2 secondary outcomes
Oswestry Low Back Pain Disability Index (ODI)
Time frame: 1 day
Roland Morris Disability Questionnaire (RMDQ)
Time frame: 1 day
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 20 Nov 2025.
- Background: PubMed 25741417Zamani E, Kordi R, Nourian R, Noorian N, Memari AH, Shariati M. Low back pain functional disability in athletes; conceptualization and initial development of a questionnaire. Asian J Sports Med. 2014 Dec;5(4):e24281. doi: 10.5812/asjsm.24281. Epub 2014 Nov 10.
- Derived from this study: PubMed 41888238Aras Bayram G, Ergezen Sahin G, Sahin M, Ustundag B, Kordi R. Cross-cultural adaptation, validity, and reliability of the Turkish version of the athlete disability index. Sci Rep. 2026 Mar 27;16(1):10948. doi: 10.1038/s41598-026-44667-2.
- Link to the original article of the ADI surveyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Gülay Aras Bayram, PhD principal investigator
Medipol 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 Low Back Pain and Disability, run by Medipol 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 3 inclusion and 4 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 20 Nov 2025. 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?
Athlete Disability Index Questionnaire (ADI) (time frame: 7 days). 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 NCT06700707, which also lists 2 linked publications.
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 20 Nov 2025.