NCT05932043

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

21 days

First QC Date

June 16, 2023

Last Update Submit

January 8, 2024

Conditions

Low Back Pain

Keywords

outcome measurescommitmentpeoplepsychologybehavioural medicine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • PCS

    At the moment of the questionnaire administration

  • ODI

    At the moment of the questionnaire administration

  • pain NRS

    At the moment of the questionnaire administration

Interventions

This is a non-interventional studyDIAGNOSTIC_TEST

None (this is a non-interventional study)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Rocca

Calosso, Italy

RECRUITING

Related Publications (9)

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

    PMID: 3955482RESULT

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

    PMID: 12769135RESULT

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

    RESULT

  • 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.

    PMID: 17161752RESULT

  • 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.

    PMID: 35507483RESULT

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

    RESULT

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

    RESULT

  • 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.

    PMID: 6450426RESULT

  • 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.

    PMID: 15207508RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Barbara Rocca, BA Psychol

CONTACT

39.3333653393info.ellis.bm@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 6, 2023

Study Start

July 10, 2023

Primary Completion

July 31, 2023

Study Completion

February 29, 2024

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

IT(1)