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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04131998
Other study ID # BC9419921
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2019
Est. completion date June 10, 2023

Study information

Verified date January 2024
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 10, 2023
Est. primary completion date January 5, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 70 Years
Eligibility Inclusion Criteria: - back pain - orthopedic problems - Albanian citizens - rehabilitation center patients Exclusion Criteria: - neurological patients - no native albanian language

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Orges Lena Murcia España

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) of pain 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
Primary 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. 7 days
Primary 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. 7 days
Primary 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. 7 days
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