Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain

Recruiting now

Conditions studied: Low Back Pain

In brief

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

Key facts

Study ID

NCT07413107

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

115

Starts

2024-12-16

Expected to finish

2026-12-01

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to speak and understand Italian fluently
• Low back pain lasting at least 3 months

You may not qualify if…

• 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

Where it is running

• ICS Maugeri - Lissone — Lissone, Milano, Italy (enrolling)
• IRCCS Maugeri - Tradate — Tradate, VA, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.