Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain
RecruitingNCT07413107
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This prospective observational study aims to develop and validate an Italian version of the Waddell Disability Index (WDI-I), a self-administered questionnaire designed to assess disability related to chronic low back pain. Low back pain is a leading cause of disability worldwide, and patient-reported outcome measures are increasingly recognized as essential tools for comprehensive clinical assessment and rehabilitation planning. The study involves a standardized cross-cultural translation process, including forward and backward translations by bilingual translators and review by a panel of expert clinicians, followed by pilot testing. After consensus, the finalized Italian version (WDI-I) will undergo psychometric validation. A total of 115 adult patients with chronic low back pain (≥3 months) will be recruited from two rehabilitation centers. At baseline, participants will complete the WDI-I along with the Numeric Pain Rating Scale (NPRS), the Italian Oswestry Disability Index (ODI-I), and the Italian Pain Catastrophizing Scale (PCS-I). The WDI-I will be re-administered after 7-10 days to assess test-retest reliability. The primary endpoints are internal consistency, reliability, and construct validity of the WDI-I. Statistical analyses will include Cronbach's alpha and item-total correlations for internal consistency, intraclass correlation coefficients (ICC), standard error of measurement (SEM), and minimum detectable change (MDC) for reliability, and Spearman correlation coefficients to evaluate concurrent validity with established pain and disability measures. The study seeks to provide a reliable and valid Italian instrument for assessing disability in individuals with chronic low back pain, facilitating both clinical practice and research
Study details
- Official title
- Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain
- Conditions
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Start date
- 2024-12-16
- Primary completion
- 2026-07
- Sex
- All
- Age range
- from 18 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Ability to speak and understand Italian fluently * Low back pain lasting at least 3 months Exclusion Criteria: * Cognitive impairment (Mini-Mental State Examination \< 24) * Central or peripheral neurological disorders * Systemic diseases or severe comorbidities (acute cardiac events, acute neurological events, chronic liver or kidney disease) * Uncorrected visual impairment * Individuals receiving compensation related to work-related disability
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07413107