Clinical trial Recruiting at 2 sites Observational Ages 18 to 90

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.

More Low Back Pain trials

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment115 (estimated)
SponsorIstituti Clinici Scientifici Maugeri SpA
Academic / other
Locations2 sites (Lissone, Milano and 1 other locations)
StatusRecruiting
StartedDecember 16, 2024
Main results expectedJuly 2026
Study endsDecember 2026
Registry record updatedFebruary 17, 2026
Trial IDNCT07413107 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.