Development of the Work In Progress Questionnaire (WIP)

What Can I do for my Low Back Pain? The Work In Progress Questionnaire!

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Diagnostic test: This is a non-interventional study

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Barbara Rocca, BA Psychol; Phone Number: 39.3333653393; Email: info.ellis.bm@gmail.com

Study Locations

• Italy
  • Calosso, Italy
    • Recruiting
    • Barbara Rocca
    • Contact: Barbara Rocca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

People with non-specific low back pain. For full description od the condition, please see the definition provided within the references list (Chiarotto A et al).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: International Institute of Behavioral Medicines

Publications and helpful links

General Publications

• Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889-95.
• Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003 May;12(3):229-38. doi: 10.1023/a:1023254226592.
• de Vet HCW, Terwee CB, Mokkink LB, et al. Measurement in medicine. A practical guide. Cambridge: Cambridge University Press, 2011
• Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
• Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
• Hayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications; 2005 Nov 1.
• Sullivan MJ, Bishop SR, & Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychol Assess 1995;7:524-532
• Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
• Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: psychology; outcome measures; commitment; behavioural medicine; people
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No