Clinical trial NCT06793254: Translation, Cultural Adaptation and Validation of the Italian Version of Functional Rating Index in Patients With Chronic Low Back Pain
Official title: Translation, Cultural Adaptation and Validation of the Italian Version of Functional Rating Index in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with chronic low back pain

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Italian Version of Functional Rating Index (I-FRI)
timeFrame: Baseline
measure: Italian Version of Functional Rating Index (I-FRI)
timeFrame: After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.
Secondary outcomes:
measure: ODI (Oswestry Disability Index)
timeFrame: Baseline
measure: PCS (Pain Catastrophizing Scale)
timeFrame: Baseline
measure: pain NRS (Numerical pain Rating Scale)
timeFrame: Baseline
measure: TSK (Tampa Scale of Kinesiophobia)
timeFrame: Baseline
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Salvatore Simone Vullo
state: Sardegna
Study officials:
affiliation: Dottor
name: Salvatore Simone Vullo
role: PRINCIPAL_INVESTIGATOR
References:
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