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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is a non-interventional study | Diagnostic Test | None (this is a non-interventional study) |
| Measure | Description | Time Frame |
|---|---|---|
| Italian Version of Functional Rating Index (I-FRI) | 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). | Baseline |
| Italian Version of Functional Rating Index (I-FRI) | 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). | After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability. |
| Measure | Description | Time Frame |
|---|---|---|
| ODI (Oswestry Disability Index) | Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability | Baseline |
| PCS (Pain Catastrophizing Scale) | Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing |
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Inclusion Criteria:
Exclusion Criteria:
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People with chronic low back pain
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Simone Vullo | Dottor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salvatore Simone Vullo | Cagliari | Sardinia | 09032 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29573869 | Background | Clark S, Horton R. Low back pain: a major global challenge. Lancet. 2018 Jun 9;391(10137):2302. doi: 10.1016/S0140-6736(18)30725-6. Epub 2018 Mar 21. No abstract available. | |
| 29573870 | Background | Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Baseline |
| pain NRS (Numerical pain Rating Scale) | Numerical pain Rating Scale; score varying from 0 to 10, with higher scores indicating greater pain intensity | Baseline |
| TSK (Tampa Scale of Kinesiophobia) | 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. | Baseline |
| 22231424 | Background | Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9. |
| 18164449 | Background | Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005. |
| 27516362 | Background | Makris UE, Higashi RT, Marks EG, Fraenkel L, Gill TM, Friedly JL, Reid MC. Physical, Emotional, and Social Impacts of Restricting Back Pain in Older Adults: A Qualitative Study. Pain Med. 2017 Jul 1;18(7):1225-1235. doi: 10.1093/pm/pnw196. |
| 11148650 | Background | Feise RJ, Michael Menke J. Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions. Spine (Phila Pa 1976). 2001 Jan 1;26(1):78-86; discussion 87. doi: 10.1097/00007632-200101010-00015. |
| 20216338 | Background | Monticone M, Giorgi I, Baiardi P, Barbieri M, Rocca B, Bonezzi C. Development of the Italian version of the Tampa Scale of Kinesiophobia (TSK-I): cross-cultural adaptation, factor analysis, reliability, and validity. Spine (Phila Pa 1976). 2010 May 20;35(12):1241-6. doi: 10.1097/BRS.0b013e3181bfcbf6. |
| 21912846 | Background | Monticone M, Baiardi P, Ferrari S, Foti C, Mugnai R, Pillastrini P, Rocca B, Vanti C. Development of the Italian version of the Pain Catastrophising Scale (PCS-I): cross-cultural adaptation, factor analysis, reliability, validity and sensitivity to change. Qual Life Res. 2012 Aug;21(6):1045-50. doi: 10.1007/s11136-011-0007-4. Epub 2011 Sep 13. |
| 6450426 | Background | Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available. |
| 15928561 | Background | Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |