- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131998
Albanian Versions and Validation of Visual Analogue Scale, Back Pain and Autonomy Questionnaires (Validation)
January 23, 2024 updated by: Jasemin Todri, Universidad Católica San Antonio de Murcia
Develop and Validation of Visual Analogue Scale, 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 visual analogue scale, back pain disability and autonomy in Albania.
A feasibility, validate, test-retest reliability and observational design is estimated.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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España
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Murcia, España, Spain, 30002
- Orges Lena
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Albanian citizens with back pain and with autonomy problems who follows rehabilitation sessions in a rehabilitation center.
Description
Inclusion Criteria:
- back pain
- orthopedic problems
- Albanian citizens
- rehabilitation center patients
Exclusion Criteria:
- neurological patients
- no native albanian language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS) of pain
Time Frame: 7 days
|
Validation and test-retest of VAS scale in 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.
|
7 days
|
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.
|
7 days
|
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.
|
7 days
|
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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jasemin Todri, PhD, UCAM Universidad Catolica de Murcia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2019
Primary Completion (Actual)
January 5, 2020
Study Completion (Actual)
June 10, 2023
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 17, 2019
First Posted (Actual)
October 18, 2019
Study Record Updates
Last Update Posted (Actual)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC9419921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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