Clinical trial NCT05932043: Development of the Work In Progress Questionnaire
Official title: What Can I do for my Low Back Pain? The Work In Progress Questionnaire!
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Keywords: outcome measures
commitment
people
psychology
behavioural medicine
Lead sponsor: International Institute of Behavioral Medicines
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: WIP questionnaire
timeFrame: At the moment of the questionnaire administration
measure: WIP questionnaire
timeFrame: After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.
Secondary outcomes:
measure: PCS
timeFrame: At the moment of the questionnaire administration
measure: ODI
timeFrame: At the moment of the questionnaire administration
measure: pain NRS
timeFrame: At the moment of the questionnaire administration
Other outcomes:
Locations:
city: Calosso
country: Italy
facility: Barbara Rocca
Study officials:
References:
citation: Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889-95.
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.
citation: de Vet HCW, Terwee CB, Mokkink LB, et al. Measurement in medicine. A practical guide. Cambridge: Cambridge University Press, 2011
citation: 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.
citation: 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.
citation: Hayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications; 2005 Nov 1.
citation: Sullivan MJ, Bishop SR, & Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychol Assess 1995;7:524-532
citation: 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.
citation: 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.