Italian version of the Waddell Disability Index for chronic low back pain
Official title: Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain
Run by Istituti Clinici Scientifici Maugeri SpA · NCT07413107 · Data updated 2026-11-12
This project will test an Italian translation of the Waddell Disability Index to see if it reliably measures disability in adults with chronic low back pain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 115 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 2 sites (Lissone, Milano and 1 other locations) |
| Status | Recruiting |
| Started | December 16, 2024 |
| Main results expected | July 2026 |
| Study ends | December 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07413107 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who speak and understand Italian fluently with low back pain lasting three months or more, without major cognitive, neurological, or systemic comorbidities, are ideal candidates.
✕Probably not a fit
People who do not speak Italian, have significant cognitive impairment, major neurological or systemic disease, uncorrected visual problems, or are involved in work-compensation claims are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational project uses a standardized cross-cultural translation process (forward and backward translations) and expert clinician panel review, followed by pilot testing to produce a consensus Italian version (WDI-I). The finalized WDI-I will be given to 115 adults with low back pain lasting at least three months at two rehabilitation centers, together with measures such as the Numeric Pain Rating Scale and the Italian Oswestry Disability Index. Psychometric validation will examine reliability (including internal consistency and test-retest) and validity (including convergent and construct validity) of the WDI-I. Results will determine whether the WDI-I is appropriate for routine clinical and rehabilitation use in Italian-speaking patients.
Why it matters
Potential benefit: If successful, clinicians and therapists in Italy would have a quick, validated Italian questionnaire to better quantify disability from chronic low back pain and guide rehabilitation planning.
How similar studies have gone: Translation and psychometric validation of patient-reported outcome questionnaires is a well-established method and similar efforts for low back pain tools (for example the Italian Oswestry Disability Index) have successfully produced validated instruments.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
ICS Maugeri - Lissone
Lissone, Milano, Italy Recruiting -
IRCCS Maugeri - Tradate
Tradate, VA, Italy Recruiting
Study contacts
- Study coordinator: Umberto Massi
- Email: umberto.massi@icsmaugeri.it
- Phone: +393517169176
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.