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

NCT06793254 | Completed

• 1 other identifier: I-FRI
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (4)

• ODI (Oswestry Disability Index)

  Baseline

• PCS (Pain Catastrophizing Scale)

  Baseline

• pain NRS (Numerical pain Rating Scale)

  Baseline

• TSK (Tampa Scale of Kinesiophobia)

  Baseline

Interventions

This is a non-interventional study DIAGNOSTIC_TEST

None (this is a non-interventional study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with chronic low back pain

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Salvatore Simone Vullo

Cagliari, Sardinia, 09032, Italy

Location

Related Publications (10)

• 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.

  PMID: 29573869 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.

  PMID: 29573870 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.

  PMID: 22231424 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.

  PMID: 18164449 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.

  PMID: 27516362 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.

  PMID: 11148650 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.

  PMID: 20216338 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.

  PMID: 21912846 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.

  PMID: 6450426 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.

  PMID: 15928561 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Simone Vullo

  Dottor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 27, 2025
• Study Start: June 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: January 19, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

IT (1)