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Completed

NCT Number: NCT05860426

Confidence in the Ability to Perform Movements in Patients With Low Back 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of León

Ponferrada, León, 24400, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Other outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Universidad de León

Other

Registry information

Official study 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

Acronym: CONFI-LBP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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