Development of the Work In Progress Questionnaire

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT05932043
• Lead Sponsor: International Institute of Behavioral Medicines

Brief Summary

The aim of this study is to describe the development of the Work In Progress questionnaire, a tool designed to evaluate commitment in persons, and its psychometric validation process in the context of low back pain.

Detailed Description

The study design is cross-sectional.

The following methodology will be applied as for the development of the Work In Progress questionnaire (WIP), a tool designed to evaluate commitment in persons, and its psychometric validation:

1. item generation and selection: the first defines the content of an index and ensures the most important topics are well-thought-out. The second eliminates redundant items, and decreases the number to a total that is feasible to administer while ensuring the scale measures the construct of interest.

2. psychometric analysis: exploratory factor analysis (Cattel Scree Test, Varimax Rotation), reliability (internal consistency by Cronbach's alpha, test-retest reliability by Intraclass Correlation Coefficient 2.1), Measurement error (calculated by multiplying the standard error of measurement (SEM) by the z-score associated with the desired level of confidence (95%, in our case) and the square root of 2), and construct validity by hypothesis testing the correlations (Pearson r) with related measures (Pain Catastrophizing Scale, Oswestry Disability Scale, Numerical pain Rating Scale).

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-06
• Study Start: 2023-07-10
• Primary Completion: 2023-07-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Low Back Pain
• adult age
• reading/speaking Italian.

Exclusion Criteria

• systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases;
• refusal to adhere.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WIP questionnaire	After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.	Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment

Secondary Outcome Measures

Name	Time	Method
PCS	At the moment of the questionnaire administration	Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing
ODI	At the moment of the questionnaire administration	Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability
pain NRS	At the moment of the questionnaire administration	Numerical pain Rating Scale; score varying from 0 to 10, with higher scores indicating greater pain intensity

Trial Locations

Locations (1)

Barbara Rocca; 🇮🇹 Calosso, Italy