Italian version of the Waddell Disability Index for chronic low back pain
Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain
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 |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 2 sites (Lissone, Milano and 1 other locations) |
| Trial ID | NCT07413107 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lissone, Milano and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.