Confidence in the Ability to Perform Movements in Patients With Low Back Pain (CONFI-LBP)

July 18, 2025 updated by: Arrate Pinto Carral, Universidad de León

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.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • León
      • Ponferrada, León, Spain, 24400
        • University of Léon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients with low back pain.
  • Be able to read and understand Spanish.
  • Acceptance and signature of the informed consent.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Kinesiophobia at 3 months.
Time Frame: Recruitment, "physiotherapy discharge" (week 3) and 3 months later.
Tampa scale of kinesiophobia (TSK-11), spanish version. Total score ranges from 11-44 points, with higher scores indicating worse outcome (greater fear).
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.
Oswestry disability index (ODI), spanish version. Total score ranges from 0-100 points, with higher scores indicating worse outcome (greater disability).
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.
STart Back screening tool (SBST-9), spanish version. Total score ranges from 0-9 points, with higher scores indicating worse outcome (greater risk).
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.
Numerical Pain Rating Scale (NPRS). Total score ranges from 0-10 points, with higher scores indicating worse outcome (higher pain).
Recruitment, "physiotherapy discharge" (week 3) and 3 months later.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy.
Time Frame: Recruitment.
Chronic Pain Self-efficacy scale, spanish version. Total score ranges from 0-100 points, with higher scores indicating better outcome (higher efficacy).
Recruitment.
Socio-demographic information.
Time Frame: Recruitment.
age, sex, area of residence, marital status, educational level, employment status, weight, height, chronic diseases, treatments, frequency of physical activity, walking assistance, location of pain, sleep disorders.
Recruitment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de León

Investigators

  • Study Director: Arrate Pinto-Carral, Ph Dr, Universidad de León
  • Study Director: Mª José Álvarez-Álvarez, Ph Dr, Universidad de León

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULE-003-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe