NCT04131998

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2020

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

October 15, 2019

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    7 days

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Albanian citizens with back pain and with autonomy problems who follows rehabilitation sessions in a rehabilitation center.

You may qualify if:

  • back pain
  • orthopedic problems
  • Albanian citizens
  • rehabilitation center patients

You may not qualify if:

  • neurological patients
  • no native albanian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orges Lena

Murcia, España, 30002, Spain

Location

Related Publications (2)

  • 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.

  • Lena 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.

MeSH Terms

Conditions

Back PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jasemin Todri, PhD

    UCAM Universidad Catolica de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 18, 2019

Study Start

November 20, 2019

Primary Completion

January 5, 2020

Study Completion

June 10, 2023

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations