Low Back PainCONFI-LBPNCT05860426
Confidence in the Ability to Perform Movements in Patients With Low Back Pain
An observational study of Low Back Pain, run by Universidad de León at 1 site in Spain.
Trial summary
The goals of this observational study are: To determine the validity and reliability of the OPTIMAL-confidence scale in people with chronic low back pain. To assess the influence of confidence and fear of movement on the evolution of low back pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 141 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2022to 31 May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients assigned to primary and specialized care health centers in the province of Leon (Spain), who were diagnosed with low back pain by their referring physician.
Who may be able to join
- Patients with low back pain.
- Be able to read and understand Spanish.
- Acceptance and signature of the informed consent.
Who cannot join
- Tumor and/or infection related to the back.
- Cauda equina syndrome.
- Vertebral compression fracture.
- Abdominal aneurysm.
- Central nervous system disorders.
- Confirmed diagnosis of active neoplasm.
- Presence of cognitive deficits that prevented participation in the study.
- Pregnant patients in the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Confidence in the Ability to Perform Movements in Patients With Low Back Pain and Its Relationship With the Characteristics and Evolution of Pain
The goals of this observational study are:
To determine the validity and reliability of the OPTIMAL-confidence scale in people with chronic low back pain.
Read more
To assess the influence of confidence and fear of movement on the evolution of low back pain.
The main question it aims to answer is if people with chronic low back pain present different psychoemotional variables around fear of movement and decreased confidence in their ability to perform movement that may influence their low back pain.
For this purpose, a two-phase study was designed. In the first phase, the OPTIMAL-confidence scale will be validated in patients with chronic low back pain, determining its internal consistency and validity. In the second phase, a prospective study will be carried out with patients with low back pain who attend physiotherapy centres to determine how confidence and fear of movement influence the characteristics of pain and its evolution. Data will be collected at the beginning of the physiotherapy treatment, at the end of the treatment and after three months. The data will be analysed using learning machine techniques.
Read the detailed description
In the first phase of the study, a sample of patients diagnosed with chronic low back pain will bwe selected, as well as a general population of convenience. The scope of the study is the health centres of the Primary Care Management of León and El Bierzo. To calculate the optimal sample size, the criteria included in the COSMIN20 guide (Consensus-based standards for the selection of health measurement instruments) were taken into account, taking as a reference the maximum quality criterion for hypotheses testing, which states that they should be equal to or greater than 100 subjects.
The second phase will consist of a prospective observational study among patients with low back pain selected by physiotherapists and interested in participating in the study. Data will be collected at three different times: at recruitment and at the end of treatment, in person, and three months after the end of treatment, by telephone.
The scope of the study will be the Primary and Specialised Health Care Departments of León and El Bierzo.
In both cases participants will sign an informed consent form and the physiotherapists who will collect the data will be trained by researchers.
Patients will complete socio-demographic and health questions as well as validated questionnaires on confidence, self-efficacy, fear of movement, risk of chronification and disability. Participants in the second phase will complete the questionnaires not only at the beginning, but two more times.
In the validation phase of optimal-confidence, the internal consistency of the scale will be analysed, as well as convergent and known-groups validity.
In the second phase, the data will be analysed using machine learning techniques. In order to find out which variables are most influential in the evolution of low back pain, different variations of the following machine learning techniques will be used: Gaussian Naive Bayes, Complement Naive Bayes, K-Nearest Neighbours (KNN and decision trees. Experiments using oversampling techniques such as RandomOver and Smote will also be carried out.
- Conditions
- Low Back Pain
- Keywords
- Low Back Ache, Lumbago, Self Efficacy, Kinesiophobia, Machine Learning
- Medical subject headings
- Low Back Pain, Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Confidence at 3 months
Outpatient Physical Therapy Improvement in Movement Assessment Log (OPTIMAL) instrument, confidence scale, spanish version. Total score ranges from 0-100 points, with higher scores indicating worse outcome (lower confidence).
Measured: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Secondary outcomes (4)
Change from Baseline Kinesiophobia at 3 months.
Tampa scale of kinesiophobia (TSK-11), spanish version. Total score ranges from 11-44 points, with higher scores indicating worse outcome (greater fear).
Measured: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Change from Baseline Disability at 3 months.
Oswestry disability index (ODI), spanish version. Total score ranges from 0-100 points, with higher scores indicating worse outcome (greater disability).
Measured: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Change from Baseline Risk at 3 months.
STart Back screening tool (SBST-9), spanish version. Total score ranges from 0-9 points, with higher scores indicating worse outcome (greater risk).
Measured: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Change from Baseline Intensity of pain at 3 months.
Numerical Pain Rating Scale (NPRS). Total score ranges from 0-10 points, with higher scores indicating worse outcome (higher pain).
Measured: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start2 Nov 2022
- Primary completion1 Feb 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arrate Pinto Carral, Universidad de León
- Investigators
- Arrate Pinto-Carral, Ph Dr, Study director, Universidad de LeónMª José Álvarez-Álvarez, Ph Dr, Study director, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860426
- Sponsor's protocol ID
- ULE-003-2021
- Acronym
- CONFI-LBP
- Status last verified
- Jul 2025
- First submitted
- 26 Apr 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For safety, the researchers only plan to use the data collected as a whole and prefer to safeguard the database generated only for this research. However, it could be made available to other researchers upon request for justified purposes such as new studies.
Publications
Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
PubMed 22466247George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
PubMed 34719942Guccione AA, Mielenz TJ, Devellis RF, Goldstein MS, Freburger JK, Pietrobon R, Miller SC, Callahan LF, Harwood K, Carey TS. Development and testing of a self-report instrument to measure actions: outpatient physical therapy improvement in movement assessment log (OPTIMAL). Phys Ther. 2005 Jun;85(6):515-30.
PubMed 15921473Pinto-Carral A, Fernandez-Villa T, Guccione AA, Cuadrado FM, Cancela JM, Molina AJ. Validity, Reliability, and Responsiveness of the Spanish Version of the OPTIMAL Instrument. PM R. 2019 Mar;11(3):258-269. doi: 10.1016/j.pmrj.2018.05.021. Epub 2019 Jan 22.
PubMed 29860022Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Pain Med. 2014 Aug;15(8):1249-67. doi: 10.1111/pme.12538.
PubMed 25132307Gusi N, del Pozo-Cruz B, Olivares PR, Hernandez-Mocholi M, Hill JC. The Spanish version of the "STarT Back Screening Tool" (SBST) in different subgroups. Aten Primaria. 2011 Jul;43(7):356-61. doi: 10.1016/j.aprim.2010.05.019. Epub 2011 Feb 5.
PubMed 21296465Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008 May 15;59(5):632-41. doi: 10.1002/art.23563.
PubMed 18438893Benitez-Andrades JA, Laballos-Gonzalez L, Pujante-Otalora L, Nieto-Marcos S, Pinto-Carral A, Alvarez-Alvarez MJ. Machine learning-based prediction of disability in subacute low back pain: a primary care study on clinical and psychosocial determinants. BMC Med Inform Decis Mak. 2026 Feb 21;26(1):92. doi: 10.1186/s12911-026-03384-6.
PubMed 41723453
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Confidence in the Ability to Perform Movements in Patients With Low Back Pain and Its Relationship With the Characteristics and Evolution of Pain
- ClinicalTrials.gov ID
- NCT05860426
- Acronym / sponsor ID
- CONFI-LBP / ULE-003-2021
- Conditions
- Low Back Pain
- Keywords
- Low Back Ache, Lumbago, Self Efficacy, Kinesiophobia, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 May 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 goals of this observational study are:
To determine the validity and reliability of the OPTIMAL-confidence scale in people with chronic low back pain.
To assess the influence of confidence and fear of movement on the evolution of low back pain.
The main question it aims to answer is if people with chronic low back pain present different psychoemotional variables around fear of movement and decreased confidence in their ability to perform movement that may influence their low back pain.
For this purpose, a two-phase study was designed. In the first phase, the OPTIMAL-confidence scale will be validated in patients with chronic low back pain, determining its internal consistency and validity. In the second phase, a prospective study will be carried out with patients with low back pain who attend physiotherapy centres to determine how confidence and fear of movement influence the characteristics of pain and its evolution. Data will be collected at the beginning of the physiotherapy treatment, at the end of the treatment and after three months. The data will be analysed using learning machine techniques.
Detailed description
In the first phase of the study, a sample of patients diagnosed with chronic low back pain will bwe selected, as well as a general population of convenience. The scope of the study is the health centres of the Primary Care Management of León and El Bierzo. To calculate the optimal sample size, the criteria included in the COSMIN20 guide (Consensus-based standards for the selection of health measurement instruments) were taken into account, taking as a reference the maximum quality criterion for hypotheses testing, which states that they should be equal to or greater than 100 subjects.
The second phase will consist of a prospective observational study among patients with low back pain selected by physiotherapists and interested in participating in the study. Data will be collected at three different times: at recruitment and at the end of treatment, in person, and three months after the end of treatment, by telephone.
The scope of the study will be the Primary and Specialised Health Care Departments of León and El Bierzo.
In both cases participants will sign an informed consent form and the physiotherapists who will collect the data will be trained by researchers.
Patients will complete socio-demographic and health questions as well as validated questionnaires on confidence, self-efficacy, fear of movement, risk of chronification and disability. Participants in the second phase will complete the questionnaires not only at the beginning, but two more times.
In the validation phase of optimal-confidence, the internal consistency of the scale will be analysed, as well as convergent and known-groups validity.
In the second phase, the data will be analysed using machine learning techniques. In order to find out which variables are most influential in the evolution of low back pain, different variations of the following machine learning techniques will be used: Gaussian Naive Bayes, Complement Naive Bayes, K-Nearest Neighbours (KNN and decision trees. Experiments using oversampling techniques such as RandomOver and Smote will also be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assigned to primary and specialized care health centers in the province of Leon (Spain), who were diagnosed with low back pain by their referring physician.
Key inclusion criteria (3 listed)
- Patients with low back pain.
- Be able to read and understand Spanish.
- Acceptance and signature of the informed consent.
Key exclusion criteria (8 listed)
- Tumor and/or infection related to the back.
- Cauda equina syndrome.
- Vertebral compression fracture.
- Abdominal aneurysm.
- Central nervous system disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline Confidence at 3 months
Time frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Outpatient Physical Therapy Improvement in Movement Assessment Log (OPTIMAL) instrument, confidence scale, spanish version. Total score ranges from 0-100 points, with higher scores indicating worse outcome (lower confidence).
4 secondary outcomes
Change from Baseline Kinesiophobia at 3 months.
Time frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Change from Baseline Disability at 3 months.
Time frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Change from Baseline Risk at 3 months.
Time frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Change from Baseline Intensity of pain at 3 months.
Time frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 22466247Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
- Background: PubMed 34719942George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
- Background: PubMed 15921473Guccione AA, Mielenz TJ, Devellis RF, Goldstein MS, Freburger JK, Pietrobon R, Miller SC, Callahan LF, Harwood K, Carey TS. Development and testing of a self-report instrument to measure actions: outpatient physical therapy improvement in movement assessment log (OPTIMAL). Phys Ther. 2005 Jun;85(6):515-30.
- Background: PubMed 29860022Pinto-Carral A, Fernandez-Villa T, Guccione AA, Cuadrado FM, Cancela JM, Molina AJ. Validity, Reliability, and Responsiveness of the Spanish Version of the OPTIMAL Instrument. PM R. 2019 Mar;11(3):258-269. doi: 10.1016/j.pmrj.2018.05.021. Epub 2019 Jan 22.
- Background: PubMed 25132307Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Pain Med. 2014 Aug;15(8):1249-67. doi: 10.1111/pme.12538.
- Background: PubMed 21296465Gusi N, del Pozo-Cruz B, Olivares PR, Hernandez-Mocholi M, Hill JC. The Spanish version of the "STarT Back Screening Tool" (SBST) in different subgroups. Aten Primaria. 2011 Jul;43(7):356-61. doi: 10.1016/j.aprim.2010.05.019. Epub 2011 Feb 5.
- Background: PubMed 18438893Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008 May 15;59(5):632-41. doi: 10.1002/art.23563.
- Derived from this study: PubMed 41723453Benitez-Andrades JA, Laballos-Gonzalez L, Pujante-Otalora L, Nieto-Marcos S, Pinto-Carral A, Alvarez-Alvarez MJ. Machine learning-based prediction of disability in subacute low back pain: a primary care study on clinical and psychosocial determinants. BMC Med Inform Decis Mak. 2026 Feb 21;26(1):92. doi: 10.1186/s12911-026-03384-6.
- Individual participant dataSharing planned: No. For safety, the researchers only plan to use the data collected as a whole and prefer to safeguard the database generated only for this research. However, it could be made available to other researchers upon request for justified purposes such as new studies.
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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.
Arrate Pinto-Carral, Ph Dr study director
Universidad de León
Mª José Álvarez-Álvarez, Ph Dr study director
Universidad de León
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 Universidad de León at 1 site in Spain.
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 8 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: finished, as of the sponsor's last update on 23 Jul 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Confidence at 3 months (time frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.). 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 NCT05860426, which also lists 8 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 23 Jul 2025.