Translation, Cultural Adaptation and Validation of the Italian Version of Functional Rating Index in Patients With Chronic Low Back Pain

Completed

• Conditions: Low Back Pain

• Registration Number: NCT06793254
• Lead Sponsor: University of Cagliari

Brief Summary

Chronic Low Back Pain (cLBP) is a global health issue lasting more than 3 months, where a clear pathologic and anatomic cause of pain is not recognized. Various personal and psychosocial factors can influence the onset and chronicity of low back pain.

The Functional Rating Index (FRI) is a self-administered questionnaire composed by 10 items, scored from 0 (better condition) to 4 (worst condition), that evaluate pain, sleep, work and daily activity. The FRI's final score ranges from 0% to 100% (no disability to severe disability). The aim of the study is to translate, culturally adapt and validate the FRI in Italian (I-FRI).

Detailed Description

Chronic Low Back Pain (cLBP) is a global health issue lasting more than 3 months, where a clear pathologic and anatomic cause of pain is not recognized. Various personal and psychosocial factors can influence the onset and chronicity of low back pain. An outcome measure, in a specific context, refers to a quantifiable or observable variable used to assess and evaluate the results or effects of a particular intervention, treatment, program, or research study. The choice of appropriate outcome measures is critical in research and evaluation because it directly influences the validity and reliability of the results. There are already other validated scales translated in Italian for the evaluation of patients with cLBP, such as the Oswestry Disability Index (ODI-I). The Functional Rating Index (FRI) is a self-administered questionnaire composed by 10 items, scored from 0 (better condition) to 4 (worst condition), that evaluate pain, sleep, work and daily activity. The FRI's final score ranges from 0% to 100% (no disability to severe disability).

The aim of the study is to translate, culturally adapt and validate the FRI in Italian (I-FRI). 104 patients were recruited for this study following inclusion/exclusion criteria. After signing the informed consent, each participant completed I-FRI, Oswestry Disability Index (ODI), Tampa Scale of Kinesiophobia (TSK) and Pain Catastrophizing Scale (PCS). All the patients have done the I-FRI re-test after 7 days from the first test administration.

All statistical analyses have been performed using IBM-SPSS (Statistical Package for the Social Sciences) version 23.00.

The results have been analyzed through the calculation of the Cronbach's alpha, the Intraclass Correlation Coefficient (ICC) and the Pearson's correlation coefficient.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-07-01
• Status Verified: 2025-01
• Study Completion: 2025-01-19
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Chronic Low Back Pain
• Adult age
• Reading/speaking Italian.

Exclusion Criteria

• Acute low back pain (lasting up to 4 weeks) or subacute low back pain (lasting up to 12 weeks).
• Cognitive impairment.
• Disabling pathological conditions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Italian Version of Functional Rating Index (I-FRI)	After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.	self-administered questionnaire composed by 10 items, scored from 0 (better condition) to 4 (worst condition), that evaluate pain, sleep, work and daily activity. The FRI's final score ranges from 0% to 100% (no disability to severe disability).

Secondary Outcome Measures

Name	Time	Method
ODI (Oswestry Disability Index)	Baseline	Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability
PCS (Pain Catastrophizing Scale)	Baseline	Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing
pain NRS (Numerical pain Rating Scale)	Baseline	Numerical pain Rating Scale; score varying from 0 to 10, with higher scores indicating greater pain intensity
TSK (Tampa Scale of Kinesiophobia)	Baseline	This self-report questionnaire assesses fear-avoidance behaviors. The investigators used the Italian 13-item version, with the reversed items removed, which has proven to be reliable and valid. Each item is scored using a four-point Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The total score is calculated by summing the individual item scores (range 13-52), with higher scores indicating greater kinesiophobia.

Trial Locations

Locations (1)

Salvatore Simone Vullo; 🇮🇹 Cagliari, Sardegna, Italy