Back PainValidationNCT04131998
Albanian Versions and Validations of Pain Assessment Tools, Back Pain and Autonomy Questionnaires
An observational study of Back Pain and Pain, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
A total of 200 participants are predicted to be enrolled for completing questionnaires in relation of pain assessment tools, back pain disability and autonomy in Albania. A feasibility, validate and test-retest reliability design is estimated. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Back Pain, Pain, Disability Physical
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2019to 10 Jun 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Albanian citizens with back pain and with autonomy problems who follows rehabilitation sessions in a rehabilitation center.
Who may be able to join
- back pain
- orthopedic problems
- Albanian citizens
- rehabilitation center patients
Who cannot join
- neurological patients
- no native albanian language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Develop and Validation of Pain Assessment Tools, Back Pain Disability and Autonomy Questionnaires in Albanian Language
A total of 200 participants are predicted to be enrolled for completing questionnaires in relation of pain assessment tools, back pain disability and autonomy in Albania. A feasibility, validate and test-retest reliability design is estimated.
Read the detailed description
This study consist of two parts, firstly translation and cross-cultural adaptation of pain and automaton questionnaires into albanian language and secondly psychometric evaluation of the questionnaires including test-retest reliability in Albanian health care centers/ hospitals .
- Conditions
- Back Pain, Pain, Disability Physical
- Medical subject headings
- Back Pain, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment Tools
Validation and test-retest of Pain Assessment tools Albanian language. VAS scale consists in identifying the patient, on a 100 cm line, referring to the point that best represents his pain, where 0 means no pain and 100 = worst possible pain.
Measured: 7 days
Roland-Morris Questionnaire (RMQ) for athletes physical disability
Validation of Roland Morrison Questionaire in Albanian language which measures the physical disability of athletes and consists of 24 points of functional capacity of the back. The sense of progression is: the more serious the worse is the performance.
Measured: 7 days
Barthel Index (BI) of patients autonomy
Validation of Barthel Index (BI) in Albanian language. It is used to measure performance in the basic activities of daily life. It refers to the patient's independence in all basic daily living activities. The maximum score used is 100 points and indicates independence in all the basic activities of daily life.
Measured: 7 days
Oswestry Disability Index
Validation o the Oswestry Disability Index in Albanian language is a questionnaire made up of 10 categories: (1) pain intensity, (2) personal care, (3) lifting, (4) walking, (5) sitting, (6) standing, (7) sleeping, (8) sex life, (9) social life, and (10) traveling. Each category consists of 6 items scored from 0 to 5 with the first statement scoring 0 to the last statement scoring 5. A check at the highest levels means the person is in the worst state. If more than one answer is selected, the highest score is considered.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start20 Nov 2019
- Primary completion5 Jan 2020
- Study completion10 Jun 2023
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasemin Todri, Universidad Católica San Antonio de Murcia
- Investigators
- Jasemin Todri, PhD, Principal investigator, UCAM Universidad Catolica de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131998
- Sponsor's protocol ID
- 147/35
- Acronym
- Validation
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2019
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Todri J, Gjini E, Lena O. Assessment properties of the Visual Analogue scale, Numeric Rating Scale, Face Pain Scale, and Pain Intensity Subscale of the Brief Pain Inventory in Albanian population with low back pain. Ann Med. 2025 Dec;57(1):2601406. doi: 10.1080/07853890.2025.2601406. Epub 2025 Dec 13.
PubMed 41388783Lena O, Todri J. A cross-cultural adaptation study on the validity and test-retest reliability of pain assessment tools in Albanian older adults with low back pain. Geriatr Nurs. 2026 Jan;67:103723. doi: 10.1016/j.gerinurse.2025.103723. Epub 2025 Nov 13.
PubMed 41237578
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop and Validation of Pain Assessment Tools, Back Pain Disability and Autonomy Questionnaires in Albanian Language
- ClinicalTrials.gov ID
- NCT04131998
- Acronym / sponsor ID
- Validation / 147/35
- Conditions
- Back Pain, Pain, Disability Physical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 18 Oct 2019 (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.
A total of 200 participants are predicted to be enrolled for completing questionnaires in relation of pain assessment tools, back pain disability and autonomy in Albania. A feasibility, validate and test-retest reliability design is estimated.
Detailed description
This study consist of two parts, firstly translation and cross-cultural adaptation of pain and automaton questionnaires into albanian language and secondly psychometric evaluation of the questionnaires including test-retest reliability in Albanian health care centers/ hospitals .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Albanian citizens with back pain and with autonomy problems who follows rehabilitation sessions in a rehabilitation center.
Key inclusion criteria (4 listed)
- back pain
- orthopedic problems
- Albanian citizens
- rehabilitation center patients
Key exclusion criteria (2 listed)
- neurological patients
- no native albanian language
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
Pain Assessment Tools
Time frame: 7 days
Validation and test-retest of Pain Assessment tools Albanian language. VAS scale consists in identifying the patient, on a 100 cm line, referring to the point that best represents his pain, where 0 means no pain and 100 = worst possible pain.
Roland-Morris Questionnaire (RMQ) for athletes physical disability
Time frame: 7 days
Validation of Roland Morrison Questionaire in Albanian language which measures the physical disability of athletes and consists of 24 points of functional capacity of the back. The sense of progression is: the more serious the worse is the performance.
Barthel Index (BI) of patients autonomy
Time frame: 7 days
Validation of Barthel Index (BI) in Albanian language. It is used to measure performance in the basic activities of daily life. It refers to the patient's independence in all basic daily living activities. The maximum score used is 100 points and indicates independence in all the basic activities of daily life.
Oswestry Disability Index
Time frame: 7 days
Validation o the Oswestry Disability Index in Albanian language is a questionnaire made up of 10 categories: (1) pain intensity, (2) personal care, (3) lifting, (4) walking, (5) sitting, (6) standing, (7) sleeping, (8) sex life, (9) social life, and (10) traveling. Each category consists of 6 items scored from 0 to 5 with the first statement scoring 0 to the last statement scoring 5. A check at the highest levels means the person is in the worst state. If more than one answer is selected, the highest score is considered.
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 19 Nov 2025.
- Derived from this study: PubMed 41388783Todri J, Gjini E, Lena O. Assessment properties of the Visual Analogue scale, Numeric Rating Scale, Face Pain Scale, and Pain Intensity Subscale of the Brief Pain Inventory in Albanian population with low back pain. Ann Med. 2025 Dec;57(1):2601406. doi: 10.1080/07853890.2025.2601406. Epub 2025 Dec 13.
- Derived from this study: PubMed 41237578Lena O, Todri J. A cross-cultural adaptation study on the validity and test-retest reliability of pain assessment tools in Albanian older adults with low back pain. Geriatr Nurs. 2026 Jan;67:103723. doi: 10.1016/j.gerinurse.2025.103723. Epub 2025 Nov 13.
- 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.
Jasemin Todri, PhD principal investigator
UCAM Universidad Catolica de Murcia
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 and Pain, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 4 inclusion and 2 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 19 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 Spain. 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?
Pain Assessment Tools (time frame: 7 days). The study lists 4 primary outcomes in all. 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 NCT04131998, 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 19 Nov 2025.