Albanian Versions and Validation of Visual Analogue Scale, Back Pain and Autonomy Questionnaires

Back Pain Clinical Trial

— Validation  

Official title:

Develop and Validation of Visual Analogue Scale, Back Pain Disability and Autonomy Questionnaires in Albanian Language

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131998
• Other study ID #: BC9419921
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Back Pain
• Disability Physical
• Pain, Acute

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