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

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

    • España
      • Murcia, España, Spain, 30002
        • Orges Lena

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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