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

NCT07413107 | Recruiting

• 1 other identifier: CTSM141-24 WDI
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 2

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

Conditions

Low Back Pain

Keywords

Waddell Disability Index; Low Back Pain; questionnaire; Italian; Validation

Outcome Measures

Primary Outcomes (3)

• Internal consistency

  Internal consistency is a measure of how well the items (questions) within a questionnaire work together to assess the same underlying construct or concept. It will be measured with Cronbach's alpha and item-total correlation.

  Through study completion, an average of 1 year

• Reliability

  Reliability is the extent to which an instrument yields the same results when measurements are repeated under identical or similar conditions

  Through study completion, an average of 1 year

• Construct Validity

  Construct validity refers to the extent to which a questionnaire actually measures the theoretical construct it is intended to measure. It reflects how well the instrument aligns with theoretical expectations.

  Through study completion, an average of 1 year

Study Arms (1)

Chronic low back pain

Patients with chronic low back pain (≥3 months)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Istituti Clinici Scientifici Maugeri for outpatient medical evaluation for chronic low back pain will be enrolled

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (2)

ICS Maugeri - Lissone

Lissone, Milano, 20851, Italy

RECRUITING

IRCCS Maugeri - Tradate

Tradate, VA, 21049, Italy

RECRUITING

Related Publications (3)

• Boateng GO, Neilands TB, Frongillo EA, Melgar-Quinonez HR, Young SL. Best Practices for Developing and Validating Scales for Health, Social, and Behavioral Research: A Primer. Front Public Health. 2018 Jun 11;6:149. doi: 10.3389/fpubh.2018.00149. eCollection 2018.

  PMID: 29942800 BACKGROUND

• Cheng X, Xue R. Cross-cultural adaptation and validation of simplified Chinese version of the Waddell Disability Index for patients with nonspecific low back pain in Mainland China. Medicine (Baltimore). 2023 Jul 7;102(27):e34344. doi: 10.1097/MD.0000000000034344.

  PMID: 37417595 BACKGROUND

• Waddell G, Main CJ. Assessment of severity in low-back disorders. Spine (Phila Pa 1976). 1984 Mar;9(2):204-8. doi: 10.1097/00007632-198403000-00012.

  PMID: 6233713 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Umberto Massi

CONTACT

+393517169176; umberto.massi@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 17, 2026
• Study Start: December 16, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

IT (2)