Development of the Work In Progress Questionnaire

Low Back Pain Clinical Trial

— WIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932043
• Other study ID #: 2023-001
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: January 2024
• Source: International Institute of Behavioral Medicines
• Contact: Barbara Rocca, BA Psychol
• Phone: 39.3333653393
• Email: info.ellis.bm[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 29, 2024
• Est. primary completion date: July 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Diagnostic Test:
• This is a non-interventional study
None (this is a non-interventional study)

Locations

Country	Name	City	State
Italy	Barbara Rocca	Calosso

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Behavioral Medicines

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003 May;12(3):229-38. doi: 10.1023/a:1023254226592. — View Citation

de Vet HCW, Terwee CB, Mokkink LB, et al. Measurement in medicine. A practical guide. Cambridge: Cambridge University Press, 2011

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. — View Citation

Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889-95. — View Citation

Hayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications; 2005 Nov 1.

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. — View Citation

Sullivan MJ, Bishop SR, & Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychol Assess 1995;7:524-532

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.2006.03.01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PCS	Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing	At the moment of the questionnaire administration
Secondary	ODI	Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability	At the moment of the questionnaire administration
Secondary	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