NCT07413107 Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain
| NCT ID | NCT07413107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 115 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 115 participants in total. It began in 2024-12-16 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07413107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07413107 currently recruiting?
Yes, NCT07413107 is actively recruiting participants. Contact the research team at umberto.massi@icsmaugeri.it for enrollment information.
Where is the NCT07413107 trial being conducted?
This trial is being conducted at Lissone, Italy, Tradate, Italy.
Who is sponsoring the NCT07413107 clinical trial?
NCT07413107 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 115 participants.