Development and Validation of the Italian Version of the Waddell Chronic Disability Index for People With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Internal consistency
研究概览
简要总结
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
详细描述
Rationale Low back pain is a very common condition and represents the leading cause of disability in industrialized countries, with a substantial economic and social impact.
The assessment of individuals with low back pain can be performed using physical tests (e.g., joint mobility, strength, gait) and outcome measures that evaluate pain intensity, functional limitations during daily activities, and quality of life. Over time, these latter measures have demonstrated strong reliability and validity, in some cases even surpassing the reliability and validity of physical tests. There is a growing consensus in the literature that such outcome measures, often self-completed by patients, represent an important complement to the overall assessment of individuals with low back pain and support the planning of rehabilitation programs. However, these measures are still viewed with some reluctance by healthcare professionals, despite not requiring additional assessment time and instead providing valuable supplementary information.
In this context, an outcome measure known as the Waddell Disability Index (WDI) exists. It was published in 1984 in the international journal Spine by Gordon Waddell and Chris Main and consists of a self-administered questionnaire including several activities of daily living, excluding work- and sport-related activities. The questionnaire is simple to administer and requires approximately five minutes to complete.
Considering the epidemiological background, the need for appropriate assessment tools, and the absence of a culturally adapted Italian version of the WDI, it is considered useful to develop an Italian adaptation of the WDI in individuals with low back pain and to analyze its reliability and validity properties.
Objectives The objective of this study is to produce an Italian-language version of the WDI through a cross-cultural translation procedure and to validate it in terms of internal consistency, reliability, and validity in a population of patients with chronic low back pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak and understand Italian fluently
- •Low back pain lasting at least 3 months
排除标准
- •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
研究组 & 干预措施
Chronic low back pain
Patients with chronic low back pain (≥3 months)
结局指标
主要结局
Internal consistency
时间窗: Through study completion, an average of 1 year
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.
Reliability
时间窗: Through study completion, an average of 1 year
Reliability is the extent to which an instrument yields the same results when measurements are repeated under identical or similar conditions
Construct Validity
时间窗: Through study completion, an average of 1 year
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.
次要结局
未报告次要终点