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Low Back PainNCT06793254

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

An observational study of Low Back Pain, run by University of Cagliari at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
What is being tested?
This is a non-interventional study
How many people
104 participants
Where
1 siteItaly
Study dates
1 Jun 2022to 19 Jan 2025
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: People with chronic low back pain

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Salvatore Simone Vullo

    Cagliari, Sardinia, 09032

Other trials in Italy

About this study

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).

Read the 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.

Conditions
Low Back Pain
Being tested
This is a non-interventional study
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • This is a non-interventional studyDiagnostic test

    None (this is a non-interventional study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

  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).

    Measured: After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.

Secondary outcomes (4)

  1. ODI (Oswestry Disability Index)

    Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability

    Measured: Baseline

  2. PCS (Pain Catastrophizing Scale)

    Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing

    Measured: Baseline

  3. pain NRS (Numerical pain Rating Scale)

    Numerical pain Rating Scale; score varying from 0 to 10, with higher scores indicating greater pain intensity

    Measured: Baseline

  4. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start1 Jun 2022
  3. Primary completion1 Jul 2024
  4. Study completion19 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
104 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06793254
Sponsor's protocol ID
I-FRI
Status last verified
Jan 2025
First submitted
19 Jan 2025
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29573869

  • 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.

    PubMed 29573870

  • 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.

    PubMed 22231424

  • 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.

    PubMed 18164449

  • 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.

    PubMed 27516362

  • 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.

    PubMed 11148650

  • 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.

    PubMed 20216338

  • 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.

    PubMed 21912846

  • 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.

    PubMed 6450426

  • 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.

    PubMed 15928561

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by University of Cagliari at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Italian Version of Functional Rating Index (I-FRI) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06793254, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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Clinical Trial NCT06793254 | AzTrials