Low Back PainWIPNCT05932043
Development of the Work In Progress Questionnaire
An observational study of Low Back Pain, run by International Institute of Behavioral Medicines at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- This is a non-interventional study
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2023to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Low Back Pain
- adult age
- reading/speaking Italian.
Who cannot join
- systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases;
- refusal to adhere.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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).
- Conditions
- Low Back Pain
- Being tested
- This is a non-interventional study
- Keywords
- outcome measures, commitment, people, psychology, behavioural medicine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyDiagnostic test
None (this is a non-interventional study)
What is being measured
The primary outcome is the main question the study is designed to answer.
WIP questionnaire
Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment
Measured: 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
Measured: After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.
Secondary outcomes (3)
PCS
Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing
Measured: At the moment of the questionnaire administration
ODI
Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability
Measured: 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
Measured: At the moment of the questionnaire administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start10 Jul 2023
- Primary completion31 Jul 2023
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Behavioral Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Rocca, International Institute of Behavioral Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932043
- Sponsor's protocol ID
- 2023-001
- Acronym
- WIP
- Status last verified
- Jan 2024
- First submitted
- 16 Jun 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889-95.
PubMed 3955482Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003 May;12(3):229-38. doi: 10.1023/a:1023254226592.
PubMed 12769135de 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.
PubMed 17161752Chiarotto 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.
PubMed 35507483Hayes 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.
PubMed 6450426Salaffi 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.
PubMed 15207508
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Can I do for my Low Back Pain? The Work In Progress Questionnaire!
- ClinicalTrials.gov ID
- NCT05932043
- Acronym / sponsor ID
- WIP / 2023-001
- Conditions
- Low Back Pain
- Keywords
- outcome measures, commitment, people, psychology, behavioural medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Institute of Behavioral MedicinesUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Low Back Pain
- adult age
- reading/speaking Italian.
Key exclusion criteria (2 listed)
- systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases;
- refusal to adhere.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyNone (this is a non-interventional study) | Diagnostic test | – |
Primary outcome
WIP questionnaire
Time frame: At the moment of the questionnaire administration
Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment
WIP questionnaire
Time frame: 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
3 secondary outcomes
PCS
Time frame: At the moment of the questionnaire administration
ODI
Time frame: At the moment of the questionnaire administration
pain NRS
Time frame: At the moment of the questionnaire administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Results publication: PubMed 3955482Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-specific quality of life in clinical trials. CMAJ. 1986 Apr 15;134(8):889-95.
- Results publication: PubMed 12769135Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003 May;12(3):229-38. doi: 10.1023/a:1023254226592.
- Results publicationde Vet HCW, Terwee CB, Mokkink LB, et al. Measurement in medicine. A practical guide. Cambridge: Cambridge University Press, 2011
- Results publication: PubMed 17161752Terwee 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.
- Results publication: PubMed 35507483Chiarotto 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.
- Results publicationHayes SC. Get out of your mind and into your life: The new acceptance and commitment therapy. New Harbinger Publications; 2005 Nov 1.
- Results publicationSullivan MJ, Bishop SR, & Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychol Assess 1995;7:524-532
- Results publication: PubMed 6450426Fairbank 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.
- Results publication: PubMed 15207508Salaffi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by International Institute of Behavioral Medicines at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Rocca, BA Psychol (39.3333653393, info.ellis.bm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WIP questionnaire (time frame: At the moment of the questionnaire administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932043, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.