Low Back Pain
Conditions
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.
Interventions
DIAGNOSTIC_TESTThis is a non-interventional study
None (this is a non-interventional study)
Sponsors
University of Cagliari
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Italian Version of Functional Rating Index (I-FRI) | Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed